Watson Pharmaceuticals to market first levothyroxine sodium product

Provides Watson with entry into thyroid market

Watson Pharmaceuticals Inc. (Corona, CA) announced on October 16 that that it has entered into an exclusive worldwide agreement with Jerome Stevens Pharmaceuticals Inc. to market and distribute Stevens' approved levothyroxine sodium USP tablets. Levothyroxine, a synthetic hormone used to treat hypothyroidism, is one of the most-prescribed drugs in the United States. Synthroid (Knoll Pharmaceutical Co.) is the current sales leader for this market.

Watson plans to launch the product in the United States in fourth quarter of 2000 as a brand pharmaceutical by both its General Products and Women's Health Divisions. Jerome Stevens will manufacture and supply the product. Financial terms of the transaction were not disclosed.

Jerome Stevens is the only manufacturer to date to have received FDA approval of an NDA for levothyroxine sodium USP tablets (product approval is listed under Unithroid (levothyroxine sodium) Tablets USP, Rx NDA 21-210). Although levothyroxine sodium USP tablets currently do not require FDA approval, the FDA has mandated that, as of August 2001, all orally administered forms of the levothyroxine sodium USP to be sold in the United States must be approved by the FDA pursuant to an NDA as set forth in Federal Register (62 FR 43535) and as amended in Federal Register (65 FR 24488).

Edited by Angelo DePalma
Managing Editor, Pharmaceutical Online and Drug Discovery Online
Email: adepalma@vertical.net