Teva, Bausch & Lomb receive tentative ANDA approval for generic versions of Rogaine..

TEVA, BAUSCH & LOMB RECEIVE TENTATIVE APPROVAL TO MARKET GENERIC ROGAINE beginning on Feb. 13, when Pharmacia & Upjohn's patent for the topical minoxidil 2% hair loss treatment expires. Teva's generic subsidiary Lemmon received the first tentative ANDA approval for topical minoxidil on Dec. 15; Bausch & Lomb Pharmaceuticals received tentative approval on Dec. 22.

The pending Rx-to-OTC switch of Rogaine, however, complicates the scenario for the generic minoxidil products. Upjohn hopes to win three years of Waxman/Hatch exclusivity for OTC Rogaine. The company expects a decision on approval (and exclusivity) soon. An FDA advisory committee recommended approval of the Rogaine OTC switch in November ("The Tan Sheet" Nov. 20, 1995, p. 4).

If Upjohn is awarded three years of exclusivity for the OTC product, marketing of the generic versions would be delayed until the exclusivity expires because there no longer would be a prescription product and the OTC product would be protected. However, an exclusivity award to OTC Rogaine is not a sure bet. The Waxman/Hatch Act requires new clinical data to support a grant of exclusivity; Upjohn referenced the prescription NDA clinical data to support the safety and efficacy of OTC Rogaine. The new studies conducted by the company to support the switch included consumer-use and label-comprehension studies.

The increased rate of Rx-to-OTC switches has led to increased scrutiny of the exclusivity award process. Further complicating the exclusivity issue are the kinds of nontraditional studies FDA is asking of sponsors to support Rx-to-OTC switches.

A Nov. 2 citizen petition filed by the D.C. law firm McKenna & Cuneo on behalf of an unnamed pharmaceutical client asks FDA to deny exclusivity for the pending Rx-to-OTC switch of SmithKline Beecham/Hoechst Marion Roussel's Nicorette. McKenna & Cuneo argue that consumer-use studies conducted for the Nicorette switch more closely resemble bioavailability studies than clinical studies. Bioavailability studies are specifically excluded from the Waxman/Hatch exclusivity provisions.

Teva/Lemmon has faced a similar situation with the switch of Sandoz's Tavist-1 (clemastine fumarate). At the time of the switch, Lemmon was one of two generic companies with ANDA approval for clemastine 1.34 mg. Sandoz did not receive additional exclusivity for Tavist-1. In such situations, ANDA holders are required only to update labeling to reflect the OTC status of the product before marketing a private-label OTC version of the branded product.

Pharmacia & Upjohn would like to continue marketing a prescription version of the hair-loss product at a higher dose than the pending OTC switch. The company filed an NDA for Rogaine 5% on Dec. 21.

The company is seeking approval of the higher strength product for use in men and women for hereditary hair loss. The NDA includes trials comparing minoxidil 5% to Rogaine 2% and placebo, Pharmacia & Upjohn said. The new strength would be eligible for three years of exclusivity.

Bausch & Lomb Pharmaceuticals has received seven ANDA approvals for ophthalmic products during 1995, including several first generics. The minoxidil approval falls outside of the company's core eyecare franchise. B&L does have a dermatologic presence, however, marketing the Curel skincare line.

Lemmon also was one of two companies to receive an ANDA approval in December covering a generic version of Procter & Gamble's prescription gingivitis treatment Peridex (chlorhexidine gluconate .12% oral rinse). Lemmon received approval on Dec. 15, followed by Barre National on Dec. 28. Also on Dec. 15, FDA approved Invamed's ANDA for ibuprofen 200 mg.