FDA approves 5% Rogaine for over-the-counter sales

Mich., July 1998

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."