Avacor® Hair Regrowth Blog

FDA Approved Hair Products

We've all seen the term "FDA Approved." But, do you know what it means?

The United States Food and Drug Administration (FDA) is a federal government agency in charge of keeping the American public safe by regulating food, drugs, and medical devices. When a product or item is FDA-Approved, it has been rigorously tested and thoroughly inspected, and found to be both effective and completely safe for people to use or consume.

So, how does this relate to your hair?

Well, if you are experiencing hair loss, interested in hair restoration, or just curious about the process, you will undoubtedly encounter a wide variety of products to help stimulate hair growth. Many of these products are not FDA-Approved, which should be an automatic red flag. In other words, if a product is advertised to treat a medical condition, such as hair loss, but it does not indicate anywhere that it is FDA-Approved, then you should avoid using that product. You may be taking a major health risk using a product that is not FDA-Approved to treat any medical condition.

Avacor Physician's Formulation® is an FDA-Approved hair restoration product clinically proven to revitalize hair follicles and help you grow back your very own hair. The FDA has carefully tested and inspected how the product is manufactured, what ingredients are used, how much of each ingredient is used, how the product is stored and packaged, and how the product is administered. In other words, all aspects of Avacor Physician's Formulation production, including each ingredient, the bottling process, and the recommended dosage, have been deemed completely safe and effective for consumers to use for the treatment of hair loss, according to the FDA.

Unfortunately, some consumers continue to be tricked into buying "snake oil" products, or hair loss treatments not approved by the FDA. These products can cause unhealthy and unwanted side effects, such as acne, scalp hair loss, menstrual irregularities in women, irritability, and aggression, according to Dr. Ray Sahelian. The FDA also indicates other side effects of hair growth products that are not FDA-Approved include low blood pressure, heart palpitations and other cardiac symptoms, hair discoloration, sensitivity to sunburn, itching, rash, irritation, or stinging skin. "Snake oil" products are a waste of time and money. They also taint consumer's opinions of the entire industry, making consumers skeptical of all hair loss products, including the legitimate ones. Additionally, they can add more emotional stress in your life when you buy the product and it doesn’t work, and/or causes health problems.

The good news is that the FDA is starting to crack down more on snake oil salesmen and punishing people with fines and/or jail time for trying to sell hair regrowth products to consumers that are not FDA-Approved. However, consumers still need to be aware of the product they are buying.

The active ingredient found in Avacor Physician's Formulation is Minoxidil. Currently, the FDA has approved Minoxidil in two different strengths: 5% for men and 2% for women. The Avacor product has Minoxidil levels that adhere to these requirements. If the levels were anything different than the 2% and 5% required by the FDA, the product could not be advertised as FDA-Approved, and could be recalled by the FDA at anytime.

In January of 2012, the FDA issued a press release announcing the recall of some hair regrowth products because they were unapproved new drugs, and had high levels of Minoxidil that could cause health hazards to consumers. These products had Minoxidil levels between 10 and 15%. If you are currently using a hair regrowth product, be sure to check the Minoxidil level, and consider switching to Avacor's FDA-Approved Physician's Formulation, as well as other hair care products: the Avacor® All Natural Nutricap containing the active ingredient Saw Palmetto, which is widely thought to be a DHT inhibitor; Boost! by Avacor®, which is specially formulated to thicken hair from the very first application; and our Scalp Detoxifying Shampoo, which removes dirt and oil from the scalp, ensuring effective delivery of the Minoxidil to the scalp when applied after using the shampoo. Rest assured that all our products are manufactured in facilities that meet the highest safety and quality standards today. Furthermore, all our products are safe to use, and have been formulated to either help you grow a natural, full, healthy head of hair, or to maintain healthy, clean, and stylish hair.


Shedding Hair

Shedding is a natural process for all living things. People and animals physically shed hair and skin. People trying (successfully) to lose weight shed pounds. Those hoping to make life changes shed unwanted aspects of their lives, such as unnecessary personal belongings, bad influences, or relationships with other people. Shedding, whether physical, emotional, or otherwise, is essentially a process in which you get rid of something that has served its purpose and is no longer useful to you.

When it comes to your hair, shedding naturally occurs at the end of the hair follicle growth cycle. Hairs on your head go through this cycle and naturally fall out, or shed, to make room for new hair. All people shed their hair, even those who are not experiencing male pattern baldness or female pattern baldness. However, shedding can still be alarming or frustrating, especially if the hair you shed does not grow back.

Baldness is caused by hair follicles that do not produce new hair after old hair is shed. However, according to MedicinePlus, the hair follicle remains alive, even when it stops producing hair. In other words, it is possible for an inactive hair follicle to produce hair again, even after baldness.

Enter FDA-approved hair regrowth treatment Avacor Physician's Formulation®, which is clinically proven to revitalize hair follicles in as little as two months. Once a hair follicle is revitalized, it can begin naturally producing hair again.

However, you still might experience shedding when you begin using Avacor Physician's Formulation. Do not be alarmed, as shedding is quite common, especially at the beginning of treatment. In fact, shedding after you start to use the product is a positive sign that the product is beginning to work.

The reason? At the beginning of the hair follicle growth cycle, new hairs need room to grow, so they push dead hairs out of the way as they sprout upwards. However, older hairs can still remain on your head if new ones do not begin to grow. The older hair might not naturally shed, and is not pushed out by new hair, because the hair growth cycle is essentially paused. When you revitalize the hair follicle using Avacor Physician's Formulation, the growth cycle resumes, shedding all dead hairs that have not yet fallen off on their own. If you notice shedding at the beginning of your treatment, just continue to use the product as directed.

You might also notice occasional shedding throughout your treatment. This is because shedding happens naturally, to everyone. Shedding is, in fact, a sign that hair follicles are actively eliminating old hairs as they produce new ones. Do not be concerned with the shedding; instead, pay attention to whether your hair follicles are producing new hairs to replace the ones that have been shed.

Lastly, it is important to be patient, especially at the beginning of treatment. Avacor Physician's Formulation is clinically proven to revitalize hair growth, but growing a full head of hair takes time. You will not wake up the next morning with a full head of hair, but if you stay the course and use the product as directed, you will be rewarded with rejuvenated hair follicles, and natural, new hair on your head.


The Hair Follicle Growth Cycle

All living things go through various stages or cycles of life. While the details differ from one thing to the next, all cycles include some form of birth or creation, development or maturation, and ultimately, some sort of expiration or death. Your hair is no different. Hair loss, hair restoration, and re-growth are all impacted by the hair follicle growth cycle, so let's take a closer look at that cycle to help better understand why you lose hair, and why hair restoration products, like FDA-approved Avacor Physician's Formulation®, really do work.

The hair follicle growth cycle is broken up into three phases:

  • The Anagen phase is the hair growth phase
  • The Catagen phase is a transitional phase
  • The Telogen phase is the resting phase.

The Anagen phase lasts anywhere from two to six years. This is the stage when hair follicles produce and grow individual hairs. Hairs grow about six inches a year on average, meaning that a few months into this phase, you can have hair that is a few inches long. The Anagen phase is further broken up into six stages; basic information about each stage is below.

  • Stage 1: Cell division begins; hair growth at the microscopic level
  • Stage 2: Follicle grows downward, and surrounds cells, which continue to grow
  • Stage 3: Hair begins to take shape and melanin production begins
  • Stage 4: Cells begin pigmentation (hair color)
  • Stage 5: Hair shaft begins to sprout
  • Stage 6: Follicle is completely developed

Another interesting fact about the Anagen phase is that at any given time, about 85% of the active hair follicles on your head are in this phase. As people get older, the Anagen phase might become shorter, resulting in smaller, finer hair. This is why adults sometimes experience thinning hair, and eventually, baldness.

The Catagen phase lasts one to two weeks in most cases. During this phase, the follicle base and hair shaft continue to move upward, thought the follicle shrinks to about 16% of the normal size.

The Telogen phase lasts between one and two months. During this phase, the hair does not grow, but it remains attached to the follicle. It is sometimes referred to as the "resting phase" because the hair basically just rests, without growing or falling out (shedding). Roughly 10 to 15% of all hair is in the Telogen phase at any given time.

At the end of the Telogen phase, the follicle starts the cycle over again. The old hair from the previous cycle either falls out on its own, or is pushed out when the new hair begins to grow in the Anagen phase.

Each hair follicle is on its own unique schedule of this growth cycle. If they were all in sync, you would lose all your hair at the same time, and regrow it at the same time. Because of the varying schedules, your hair is constantly growing, shedding, and growing again, simultaneously.

When you begin treatment to regrow or rejuvenate hair growth using Avacor Physician's Formulation, it is important to be patient. Your hair will not grow back overnight. Avacor Physician's Formulation has been clinically proven to revitalize hair follicles in as little as two months. However, when hair follicles are revitalized, they must still go through the hair follicle growth cycle to begin growing new strands of hair. Specifically, once revitalization occurs, the follicles must go through at least a few months of the Anagen phase to generate new hair that is a few inches long.

Stay tuned for the next post, which will discuss shedding in more detail.


History of Hair Loss (Part 2)

History of Hair Loss (Part 2): Symbolism of Hair

Let's face it – our hair is important for many reasons. It gives us confidence, keeps our heads warm, allows us to express our own styles, serves as a status symbol, attracts people to us, represents our age, and even offers a glimpse into our personal health. Throughout history, and even in today's modern world, hair has played several roles and represented different social and cultural symbols. Similarly, hair loss has represented various symbols or ideas over time. Let's look at a few examples.

In the Bible story about Samson and Delilah, hair played a vital role in the outcome, and symbolized Samson's strength. At an early age, Samson took the Nazarite vow to never cut his hair. He believed his strength came from his full head of long hair. Samson fell for a woman named Delilah, who was secretly working for Philistine rulers, and told her about his hair as a source of strength. She used this information against him, and arranged for someone to shave seven braids from his head while he slept.

He awoke feeling weak and powerless, and was forced into slave labor by the Philistines. His hair, however, began to grow back, and ultimately rejuvenated his strength. Powerful again, but still in captivity, Samson used his bare hands to bring down the temple from within, killing him and all his enemies inside.

Was the hair really his strength, or was it a symbol for his physical power and faith? We don't know for sure, but anyone who has had successful hair restoration treatment can relate to the feeling of rejuvenation and power that comes from a fully restored head of hair.

The Bible didn't leave out women when it came to hair symbolism, either. 1 Cor. 11:15 states that "if a woman have long hair, it is a glory to her." Long hair on women was often a symbol of beauty throughout many different cultures.

Fairy tales also use hair as symbols or important elements of the plot. Rapunzel famously used her long hair to help a prince climb to see her, and when her witch captor found out, the witch cut off Rapunzel's hair – and her purity and innocence. The blonde, curly hair worn by Goldilocks also gave her story about her encounter with three bears its name.

A common rite of passage in Chinese, Egyptian, Indian, and some European countries histories was to shave children's heads, save for a few locks. Then, when the child reached the appropriate age, the lock was cut off, symbolizing the entry into adulthood.

Native Americans (and Hollywood) made scalping famous. The scalps served as a trophy of war, and also as a life force for a warrior. Some also believed that taking the hair of someone who had murdered a member of the tribe was a symbolic way to replace the murdered tribe member.

Some modern day parents keep a lock of hair from their child's first hair cut for good luck. Other societies or religions dictate whether men (or women) should have long or short hair, with penalties ranging from weird looks to physical punishment. Hair is often used scientifically in DNA tests; it is a living record of your body's history. From a fashion perspective, both men and women can wear long or short hair, depending on the facial features, current trends, and overall look or style.

Clearly, hair has played many roles throughout our history and literature. It typically symbolized purity and strength, and cutting off someone's hair was often a punishment or symbol for losing innocence or power. Losing your hair, however, is no fault of yours, and is easy to combat with Avacor Physician's Formulation®, an FDA-approved hair restoration and re-growth product that has been clinically proven to revitalize hair follicles in as little as two months. And that's no fairy tale.

Stay tuned for the next post, which will discuss the growth cycle of the hair follicle.


History of Hair Loss (Part 1)

History of Hair Loss (Part 1): Hair Loss and Remedies Over Time

If you are experiencing premature hair loss, or thinning hair, you are not alone. In fact, premature hair loss has been an issue for people throughout history. Thousands of years ago, ancient Egyptians shaved their heads and wore wigs or elaborate head pieces to combat hair loss and display royalty and wealth. They also created a variety of potions, ointments, and other methods to treat hair loss. Some ointments included boiled porcupine hair or hippopotamus fat, according to the 1550 B.C. medical text, The Ebers Papyrus. Clearly, these options would not be FDA-approved today.

The Bible also mentions hair loss a few times. In 2 Kings 2:23-24, Elisha was mocked by a number of youths, shouting "bald head" and "baldy" at him as he walked into the town of Bethel. Angered and embarrassed, he cursed them and took his revenge by summoning two bears from the woods. It didn't cure his baldness, but it also didn't end well for the youths.

Julius Caesar wore the original Caesar hair style, but he was also bothered by his hair loss. According to Suetonius, Caesar combed his "scanty locks" forward to hide his thinning head of hair. Some also speculate that he wore the traditional laurel wreath to cover up his baldness. Oddly enough, the Latin word "caesaries" translates to "long/flowing/luxuriant hair."

In the Middle Ages, King Louis XIII of France began the big wig era by wearing a long, curly wig after losing his hair prematurely. This fashion trend spread throughout Europe and across the pond to the American colonies. Many European and American politicians and scholars—men and women alike—wore large wigs, not only to be fashionable, but to hide their thinning hair or bald heads. Even after the American and French Revolutions, when the big wig was seen as a symbol of the old regime, people wore white, powdered wigs.

Cowboys in 19th century America attempted to stop thinning hair with various snake oil products and messy grease rubbed into the scalp. Also, let's not forget the infamous cowboy hats, which offered protection from the sun, and conveniently hid bald heads underneath.

In the modern era, hair loss continues to be an issue. For some people, losing hair is an emotional and stressful time, while it is a health issue for others. Hair loss can lead to lower self-esteem, high anxiety, depression, and issues with sexual attractiveness and social acceptance. It can also trigger fears about getting older, and even dying. Avacor Physician's Formulation® is an FDA-approved hair restoration and re-growth product that has been clinically proven to revitalize hair follicles in as little as two months. Thankfully, we live in a time when we do not need to rely on snake oils, obnoxiously large wigs, animal fats, or vicious bears.

Stay tuned for Part 2 of The History of Hair Loss, which will discuss the importance and symbolism of hair throughout history.


Thanks for being part of the Avacor community!

We really appreciate all the feedback we've been getting since we started the Avacor® Hair Regrowth Blog back in June of this year. We'd especially like to thank all of you, our readers, for trusting us as a source for reliable, scientifically-based information on hair loss and hair regrowth.

Many of you have either commented on a post or written to us directly. Some have simply said "keep up the good work," while others have approached us with detailed questions and concerns about their hair loss issues.

One reader (who hosts a medical show on satellite radio) tweeted that he was skeptical at first but "I read it and I was VERY impressed".

We've also received some good feedback from out in the blogosphere. A community reviewer from blogsearchengine.com said:

"If you need information on hair loss, one of the best places to look is The Avacor Hair Regrowth Blog. In this blog, you will get tons of info on the scientific reasons underlying hair loss and solutions to hair loss... If you really want to learn about the condition and how to treat it, then this blog ought to be part of your reading list!"

We would love to hear from you too! If there are any topics you would like us to cover in a future post, please feel free to drop us a line anytime and we'll try to address your suggestions with a post as soon as possible.

Thanks again for reading and being part of the Avacor® community!

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Healthy Hair: Biotin and Vitamin B12

When people hear the word “nutrition,” they usually think about keeping their body healthy and staying in shape, but you may not realize that nutrition also affects your hair. Micronutrients like vitamins and minerals are especially important for keeping hair healthy.1

The micronutrients Biotin and Vitamin B12 are two of the most recent additions to our Avacor® All Natural Nutricap, a dietary supplement specially formulated to improve the health of your hair and scalp.*

In this post we have collected a few pieces of information about Biotin and Vitamin B12 that we thought were particularly relevant to healthy hair.

Biotin May Improve Hair Quality/Thickness

Biotin, also known as Vitamin H is a micronutrient that is known to be essential for maintaining healthy hair and skin.1 (According to some sources the H actually stands for "haar und haut", German for "hair and skin".)

Biotin is absorbed into the shafts of hair, where it “moderates the damage environmental or other factors may have caused, and increases the diameter of the hair shafts.” 2

“It is well documented that biotin deficiency in humans and animals causes pathological changes in the skin and its appendages such as desquamative dermatitis and alopecia,” 3 and in animal studies, a biotin-poor diet leads to dandruff-like skin irritation and causes hair loss.4

But biotin supplementation may also be beneficial for people who do not suffer from a known biotin deficiency:

pharmacological doses of biotin have been shown to improve… the quality of nails and hair in humans in the absence of apparent biotin deficiency.” 3

Our All Natural Nutricap now contains 300 micrograms of Biotin to make sure you are getting enough of this important micronutrient.

Vitamin B12 for “Optimal Hair Growth Potential”

Vitamin B12, a water-soluble vitamin containing the element cobalt, is involved in cell metabolism and macromolecular synthesis in all cells throughout the body.

According to the scientific literature, “optimal hair growth potential” requires adequate levels of Vitamin B12 in the body.5 An article from WebMD quotes one doctor, a clinical professor of dermatology, as saying “it's not uncommon to find a B12 deficiency in women who come in seeking treatment for hair loss.”

Since Vitamin B12 is only found in certain foods, our All Natural Nutricap is now supplemented with 6 micrograms of Vitamin B12 to ensure that your body is equipped with the proper nutrition it needs to keep your hair healthy.*

Thanks for reading, we hope you've learned something new about hair and nutrition and that you enjoy the benefits of these improvements we've made to the Avacor® All Natural Nutricap!


1. Daniells S, Hardy G. Hair loss in long-term or home parenteral nutrition: are micronutrient deficiencies to blame? Curr Opin Clin Nutr Metab Care. 2010 Nov;13(6):690-7. Link

2. Goldberg, M.E. Hair enrichment composition and method of use. US Patent No. 5,069,898. December 3, 1991. Link

3. Limat A, Suormala T, Hunziker T, Waelti ER, Braathen LR, Baumgartner R. Proliferation and differentiation of cultured human follicular keratinocytes are not influenced by biotin. Arch Dermatol Res. 1996;288(1):31-8. Link

4. Morganti, P. Medicinal formulation for promoting keratinogenesis and reducing seborrhea of the face and scalp. US Patent No. 4,863,950. September 5, 1989. Link

5. Rushton DH. Management of hair loss in women. Dermatol Clin. 1993 Jan;11(1):47-53. Link

6. Photo above form Properhealthtips.com

*These statements have not been evaluated by the Food and Drug Administration. These products are not intended to diagnose, treat, cure or prevent any disease.


Getting the most out of this blog

As we accumulate more and more information about hair loss and hair regrowth here on the Avacor® Hair Regrowth Blog, some of the newer posts are beginning to build on concepts introduced in previous entries.

If you are just visiting for the first time, it may be helpful to start with the earliest posts (at the end of the site) and read backwards from there.

For information on a particular subject, be sure to utilize the “Categories” and “Tags” on the right-hand side of the page to find all of the articles on that topic.

Here are a few pieces of suggested reading to get you started:

One of our first posts highlighted the importance of addressing hair loss as early as possible. Click here to read “Carpe Diem: Delaying Treatment Affects Results?”

The “Minoxidil Mini-Series” is a five part series that provides a comprehensive overview of minoxidil, the first FDA-approved treatment for male and female pattern hair loss and the active ingredient in Avacor Physicians Formulation®.
Part 2 - Early History
Part 3 - Clinical Trials
Part 4 - FDA Approval
Part 5 - Benefits, Limitations, and Side Effects

We welcome your questions and feedback on any subject related to hair loss, hair regrowth, or Avacor products, as well as any suggestions for future topics you'd like to hear about here on the Avacor Hair Regrowth Blog, so feel free to leave a comment or contact us privately and we'll respond as quickly as possible with more information to help you find the right approach to dealing with your hair loss.


Minoxidil Mini-Series (Part 5)

Part 5 – Minoxidil Benefits, Limitations, and Side Effects

This post will conclude the Avacor® Hair Regrowth Blog's five part “mini-series” on minoxidil, the first FDA-approved treatment for hair loss. Earlier episodes of the mini-series covered the early history of minoxidil, clinical trials showing its efficacy in treating androgenetic alopecia, and its approval by the FDA as a hair regrowth treatment. In this final segment we will highlight the benefits, limitations, and side effects associated with minoxidil.

Benefits of Minoxidil Treatment

Minoxidil products, such as Avacor Physicians Formulation® and Rogaine®, have helped thousands of men and women stop their hair loss and begin regrowing hair.

Several clinical trials have proven that minoxidil is able to prevent hair loss and regrow hair, with investigators observing hair growth in anywhere from 30-60% of patients (for details see our previous post on clinical trials). These studies also suggest that even if patients do not achieve noticeable hair regrowth with minoxidil treatment, they can at least stop losing hair and maintain their baseline hair count.

Minoxidil is the only hair regrowth medication that has been approved by the FDA for both men and women, unlike finasteride (Propecia®) which is only approved for use by men.

One of the other benefits of minoxidil is that it has not been associated with the sexual side effects experienced by some patients taking finasteride (Propecia®), such as decreased arousal and erectile dysfunction.1 For a description of the side effects that have been associated with minoxidil, keep reading for the section below on “Reported Side Effects of Minoxidil.”

Minoxidil’s Limitations

There is no magic cure for hair loss, so it is important to begin any hair regrowth regimen with accurate information and reasonable expectations. Minoxidil will not work for everyone; its effectiveness is limited to certain types of hair loss and the degree of hair regrowth experienced by each person will differ. In addition, minoxidil requires a consistent, diligent program of use to achieve maximum results.

Only Works for Certain Types of Hair Loss

The only types of hair loss for which minoxidil has been approved by the FDA are male and female androgenetic alopecia. Some studies have reported positive results for a small number of patients with alopecia areata, but the benefits have not been consistent enough to recommend widespread use of minoxidil for this condition.

Men: Minoxidil 5% topical solution, (such as Avacor Physicians Formulation® for Men) is only recommended for men with male pattern hair loss, and is not intended for treating frontal baldness or a receding hairline. Despite a conference presentation by the lead investigator of several early minoxidil trials suggesting that it is also effective in the frontal hairline area,2 the supporting data do not appear to have been published in any peer-reviewed journals or evaluated by the FDA. Patients using minoxidil should not expect to regrow hair in any areas other than the top of the scalp.

Women: Minoxidil 2% topical solution, (such as Avacor Physicians Formulation® for Women) is only recommended for women with female pattern hair loss (general thinning of hair on the top of the scalp). Minoxidil products are not indicated for hair loss that is sudden, patchy, or associated with stress or childbirth.

Minoxidil may not work for patients whose hair loss is too advanced. A general visual guide that shows the degrees of thinning hair for which minoxidil is most effective can be found on Avacor's product packaging (pictured above).

Needs to be Used Consistently

In order to achieve the best possible results with minoxidil, it is essential to apply the topical solution regularly and consistently. The best way to do this is to commit to making it part of your daily routine, even if it's not your favorite part of the day. An analogy for this would be brushing your teeth: while no one particularly enjoys the act of brushing their teeth (at least that we are aware of), most people find the benefits are worth the little bit of time each day.

Like all good things, regrowing hair takes time. You may need to use minoxidil for at least 4 months before you see results, although you may begin to notice the effects as early as 2 months.

Continued use is necessary to prevent hair loss from progressing. One of the longest studies of minoxidil for male pattern hair loss (5 years) found that patients who continued to apply minoxidil twice per day were able to maintain nonvellus hair regrowth well beyond their baseline hair counts.3 Patients who stop using minoxidil will likely not maintain hair that has regrown during the course of treatment and will begin losing hair again.

Reported Side Effects of Minoxidil

More than 20 years after minoxidil was first approved for treating hair loss, the list of commonly reported side effects remains fairly limited. However, there are some rare side effects that should be watched for and taken very seriously.

Some of the most common side effects are:
• Localized scalp reactions or skin irritation (i.e., dryness, itching, redness and mild burning)
• GI discomforts (e.g., mild heartburn, nausea, constipation and diarrhea)
• Hair growth in other body areas (i.e., face, arms, back)

If you experience any of the following rare side effects, you should discontinue use immediately and consult your physician:
• Dizziness, light headedness, faintness, headaches
• Sudden unexplained weight gain, water retention
• Rapid heart beat or chest tightness/discomfort
• Swelling of the mouth, face, lips, or tongue

In addition to these side effects, some people have experienced changes in hair color and/or texture.

If you have heart disease you should talk to your doctor before using minoxidil. Minoxidil may be harmful if used when pregnant or breast-feeding, should not be used by children under the age of 18, and should be kept out of reach of children at all times.


Thanks again for checking out the “Minoxidil Mini-Series” here on the Avacor Hair Regrowth Blog. We hope the information we have collected here has given you a better understanding of the history, benefits, and limitations of minoxidil and that it will help you choose the best course of action for regrowing your hair.

If you have any questions or would like to see more information on a particular topic, please leave a comment below. We'd love to hear from you!


1. Irwig MS, Kolukula S. Persistent sexual side effects of finasteride for male pattern hair loss. J Sex Med. 2011 Jun;8(6):1747-53. Link to Pubmed

2. Olsen EA, Whiting DA, Miller JJ. Increased Frontal Scalp Coverage and Frontal Hair Regrowth with 5% and 2% Minoxidil Solution. Presented at the American Academy of Dermatology 61st Annual Meeting, March 2003.

3. Olsen EA, Weiner MS, Amara IA, DeLong ER. Five-year follow-up of men with androgenetic alopecia treated with topical minoxidil. J Am Acad Dermatol. 1990 Apr;22(4):643-6. Link to Pubmed


Minoxidil Mini-Series (Part 4)

Part 4 – FDA Approval and Transition to OTC

So far in the Avacor® Hair Regrowth Blog’s “Minoxidil Mini-Series,” we have documented the initial use of minoxidil as a blood pressure medication, the surprising discovery that it regrew hair in patients with androgenetic alopecia, and the clinical trials that eventually proved minoxidil’s effectiveness for treating hair loss.

Today the story continues with the Food and Drug Administration’s initial approval of 2% minoxidil for male pattern baldness in 1988, supplemental approvals allowing use by women and availability over-the-counter, and finally the approval of 5% minoxidil (extra-strength) for men in 1997.

FDA Approves Minoxidil for Male and Female Pattern Hair Loss

After the efficacy of minoxidil for treating hair loss was demonstrated in clinical trials (see our last post for a summary), Pharmacia & Upjohn submitted a New Drug Application (NDA) to the FDA seeking approval to market a 2% topical minoxidil solution for male pattern hair loss.

NDA 19-501 for “Rogaine® Topical Solution” presented data on the safety and efficacy of the formulation, pharmacokinetic studies of drug absorption, a statistical review of the clinical results, and proposed package labeling for the product. With its approval on August 17, 1988, minoxidil became the first-ever FDA-approved treatment for hair regrowth.

Soon after, a supplemental application was made for the use of 2% minoxidil by women suffering from female androgenetic alopecia. Supported by several clinical trials that showed the effectiveness of minoxidil for treating hair loss in women (also summarized in our last post), the application was approved in 1991 and Rogaine® became available to women on a prescription basis.

The product was a huge success, reaching sales of $100 million per year by 1995.1 On February 9, 1996, just two days before Pharmacia & Upjohn's patent on minoxidil expired, the FDA approved a supplement to NDA 19-501 allowing over-the-counter distribution of 2% minoxidil for men (in a blue package) and women (pink package).

FDA Approval of “Extra-Strength” Minoxidil (5%) for Men

Since earlier studies had shown a dose-dependent increase in the effectiveness of minoxidil for hair regeneration in men,2 it was only a matter of time before studies began to test whether doses higher than 2% minoxidil could be more effective in regrowing hair.

The results of a 48-week, double-blind, placebo-controlled, randomized, multicenter trial in 393 balding men showed that “5% topical minoxidil was clearly superior to 2% topical minoxidil,” producing an earlier response to treatment and resulting in 45% more hair regrowth without evidence of systemic effects from the increased concentration.2 In light of the clear benefits of 5% minoxidil, NDA 20-834 for “Rogaine® Extra Strength For Men (5% Topical Minoxidil Solution),” was approved by the FDA on November 14, 1997.

While the benefits for men were clear, a subsequent trial comparing 5% minoxidil to 2% minoxidil or placebo in female patients did not support its use by women.3 Although the 5% minoxidil solution proved superior to placebo (and resulted in favorable impressions from patients), it did not provide a statistically significant benefit over 2% minoxidil for any of the objective measures of hair regrowth.

Avacor Products’ ANDA for Minoxidil

When Pharmacia & Upjohn’s patents covering topical minoxidil for hair regrowth expired, other companies received FDA approval through the Abbreviated New Drug Application (ANDA) process to manufacture and sell minoxidil for hair regrowth. Avacor Products LLC currently holds such approval in the form of ANDA #075619 and provides topical minoxidil solutions (Avacor Physicians Formulation®) for both men and women.

Make sure to tune in next week when we wrap up the story with the final episode of the Avacor Hair Regrowth Blog’s “Minoxidil Mini-Series.” Our goal with this blog is to provide you with the information you need so that you can make an informed decision about your approach to hair regrowth; part of this process is making sure you have a clear understanding of what you can and cannot expect from using minoxidil.

In the last installment we will give a summary of the benefits that minoxidil can provide, but also explain the limitations and potential side effects you might experience. In the end we hope that having all this information in one place will make it easier for you to navigate the world of hair regrowth treatments and find the right solution for you.


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2. Shupack JL, Kassimir JJ, Thirumoorthy T, Reed ML, Jondreau L. Dose-response study of topical minoxidil in male pattern alopecia. J Am Acad Dermatol. 1987 Mar;16(3 Pt 2):673-6. Link to PubMed

3. Olsen EA, Dunlap FE, Funicella T, Koperski JA, Swinehart JM, Tschen EH, Trancik RJ. A randomized clinical trial of 5% topical minoxidil versus 2% topical minoxidil and placebo in the treatment of androgenetic alopecia in men. J Am Acad Dermatol. 2002 Sep;47(3):377-85. Link to PubMed

4. Lucky AW, Piacquadio DJ, Ditre CM, Dunlap F, Kantor I, Pandya AG, Savin RC, Tharp MD. A randomized, placebo-controlled trial of 5% and 2% topical minoxidil solutions in the treatment of female pattern hair loss. J Am Acad Dermatol. 2004 Apr;50(4):541-53. Link to PubMed