Duramed Takes On FDA Over Generic Premarin Block

Duramed Pharmaceuticals has filed a Citizen Petition with the US Foodand Drug Administration, asking that American Home Products' Premarin brand of conjugated estrogens be declared deficient in its labeling in that it fails to identify its active ingredients.

The generic firm has gone on the offensive after FDA action blocked its bid to get a generic onto the market (Marketletter May 12). Duramed's petition notes that under the USA's Food, Drug and Cosmetic Act, a drug is misbranded unless "its label bears...the established name and quantity of each active ingredient." The FDA had declined to approve synthetic forms of Premarin, because it said that no identical form could be made "until the active ingredients are sufficiently defined."

Duramed insists that AHP should amend the labeling for Premarin to reflect this, and that the company should also not be able to gain approval for any new dosage strengths or new indications for Premarin, alone or in combination, until it can satisfy the requirements of the Act. Duramed accuses the FDA of double standards.