FDA approves 5% Rogaine for over-the-counter sales
KALAMAZOO, Mich., July 15
By a vote of 13-4, the Nonprescription Drugs
Advisory Committee and the Dermatologic and Ophthalmic Drugs Advisory Committee
today recommended that based on safety and effectiveness of the product,
Rogaine Extra Strength for Men should be made available for over-the-counter
(OTC) sales. "We are extremely pleased with the recommendation from the
advisory panel," said Michael J. Valentino, president Pharmacia &
Upjohn Consumer Healthcare U.S. "We look forward to working on this
recommendation with the FDA in the upcoming weeks to quickly move Rogaine Extra
Strength for Men toward marketing clearance."
Pharmacia & Upjohn presented results from clinical studies to the
committees showing that Rogaine Extra Strength for Men will grow up to 46% more
hair for men than regular strength Rogaine, with the onset of hair regrowth
occurring at eight weeks compared to the current regular strength Rogaine which
begins regrowing hair at 16 weeks. The two advisory committees concluded that
while Rogaine Extra Strength for Men may, in fact, be used by some women, its
availability in the marketplace would not pose a health risk for them.
The main side effect of Rogaine Extra Strength for Men, irritation of the
scalp, was reported by some patients in clinical studies. Irritation of the
scalp (itching and dryness) is the most common side effect associated with
regular strength Rogaine as well.
Outside the United States, Rogaine Extra Strength for Men is marketed to both
men and women under the brand name Regaine in 14 countries, including two
countries as a non-prescription product. The first country to receive approval
was New Zealand in 1993. Pharmacia & Upjohn researchers are continuing work
with the FDA on the Rogaine Extra Strength product for women, targeting it for
over-the-counter clearance in the near future.
Regular strength Rogaine was approved for men as a prescription product in
August of 1988 and for women in August of 1991. Rogaine for Men and Rogaine for
Women were cleared for over-the-counter sale in February of 1996. A New Drug
Application (NDA) was submitted for Rogaine Extra Strength for Men as a
prescription product in December of 1995 and reached approvable status in
December of 1996. Pharmacia & Upjohn elected not to pursue final approval
as a prescription drug, but instead filed a New Drug Application in February of
1997 seeking over-the-counter clearance.
"Once we gained the over-the-counter experience from the regular strength
product, it was evident to us that Rogaine Extra Strength for Men should go
directly OTC as well," said Valentino. "It is safe and grows more
hair faster. The demand is there."
