Strength for Men, also known as Regaine 5% outside of the U.S.A., and generic
Minoxidil are available online.
Rogaine is a registered trademark of Pharmacia & Upjohn Consumer Healthcare.
FDA Clears Rogaine Hair Regrowth Treatment for OTC sale.
KALAMAZOO, Mich., Feb. 12, 1996 -- Pharmacia & Upjohn,
Inc. (NYSE: PNU) announced today that the United States Food and Drug Administration
(FDA) has approved Rogaine Hair Regrowth Treatment for over-the-counter
(OTC) sale. Rogaine becomes the only medically proven OTC hair regrowth
treatment for men and women with common hereditary hair loss. The company
has requested FDA to approve a three-year period of marketing exclusivity
for OTC Rogaine.
"We are pleased with the FDA's
decision switching Rogaine, from prescription to OTC status," said
Thomas M. Laughlin, Senior Vice President Worldwide Consumer Pharmaceuticals
and General Manager Consumer Pharmaceuticals U.S. for Pharmacia & Upjohn.
"OTC availability of Rogaine is a welcome
convenience for the millions of men and women who experience common hair
loss. We are pursuing an aggressive timetable to make Rogaine quickly and
widely accessible to consumers."
Upon availability, consumers will be able to locate Rogaine in the pharmacy or hair care sections of food, drug and mass merchandiser retail outlets. Before using Rogaine, however, consumers should determine whether it is appropriate for their hair loss. If there is no family history of gradual hair loss, if hair loss is sudden or patchy or accompanied by other symptoms, or if consumers are unsure of the cause of their hair loss, then consultation with a physician is recommended before Rogaine is used. The amount of hair regrowth will vary by person and not everyone will respond to Rogaine treatment. Separate packages, Rogaine for Men and Rogaine for Women, will contain labeling and illustrations designed to help consumers accurately identify themselves as Rogaine candidates. A free consumer education brochure will also be available wherever Rogaine is sold. Package labeling and the educational brochure also will explain directions for use and address consumer questions of concern.
In December 1995, Pharmacia & Upjohn submitted a New Drug Application to the FDA for a Rogaine five-percent minoxidil formulation to treat common hair loss. Over-the-counter Rogaine is a two-percent minoxidil formulation. The company believes it could receive marketing clearance for this prescription-only hair regrowth treatment later this year. In the United States, approximately 40 million men and 20 million women experience common hair loss, also known as androgenetic alopecia or male pattern baldness. This condition accounts for approximately 95 percent of all hair loss cases in the U.S. and is the only type of hair loss for which Rogaine is indicated. Introduced in the U.S. for men in 1988 and for women in 1991, Rogaine is marketed in more than 80 countries. It is currently approved for sale without a prescription in 12 countries, including Denmark, The Netherlands, New Zealand, Spain and United Kingdom. OTC status is pending in several other countries. Rogaine annual sales in 1994 were $122 million worldwide, including $96 million in the U.S. Through the first nine months of 1995, sales were $92 million worldwide, including $72 million in the U.S.
Pharmacia & Upjohn, Inc. is a research-based pharmaceutical company dedicated to improving the quality of life for people around the world. The company was formed through a merger of the worldwide operations of Pharmacia AB and The Upjohn Company and began operating in November 1995. Pharmacia & Upjohn is a provider of human health care products, animal health products, diagnostics, biotech supply and specialty chemicals. The company's corporate management center is located in London.
All Rights Reserved.