WASHINGTON (FNS) -- Applications to market over-the-counter versions of Rogaine (monoxidil), Tagamet (cimetidine) and Pepcid (famotidine) are pending final review by the Food and Drug Administration.
Approval of any of the three applications is considered unlikely, because FDA advisory panels last month recommended against switching the drugs to OTC status. FDA typically, although not always, follows the recommendations of its advisory committees.
Rogaine, a product of Upjohn, Kalamazoo, Mich., is used to treat baldness. Tagamet and Pepcid are anti-ulcer drugs marketed by SmithKline Beecham, Philadelphia, and Merck, Rahway, N.J., respectively.
All three manufacturers say they will work with FDA to address concerns.
In the case of Rogaine, the panel noted that increased hair counts were limited and concluded a doctor's supervision was needed in order for patients to receive Rogaine's maximum effect.
"There were no data presented at the meeting that dispute Rogaine's safety and efficacy," said Upjohn. "One issue raised by the advisory committee concerned the possible need for physician diagnosis of hair loss. Upjohn believes this can be handled in the labeling." Concern about Tagamet's interaction with three other medications led the panel to reject the ulcer drug's OTC application. The company argued that the warnings provided on the label would be sufficient. The three drugs in question are theophylline, warfarin and phenytoin.
"Hopefully we will be able to work things out with FDA," a SmithKline spokesman said.
FDA reviewers also took issue with Merck's statistical analysis of its clinical test results of Pepcid, and concluded that Merck didn't demonstrate that the drug consistently provided relief from heartburn or prevented it.
Despite the panels' actions, FDA isn't cooling toward the idea of reclassifying prescription drugs for sale over the counter, according to the Nonprescription Drug Manufacturers Association. A spokeswoman noted that an FDA advisory panel initially rejected the OTC application for the pain reliever naproxen sodium, but Syntex later secured the switch after addressing FDA's concerns over labeling and dosage.
