Yesterday, October 13, FDA sent Warning Letters to four manufacturers of Codeine Sulfate tablets, 30 and 60 mg: Lehigh Valley Technologies, Inc., Cerovene Inc., Dava International, Inc., and Glenmark Generics, Inc., for marketing a product without an approved application. The manufacturers have 15 days to cease manufacturing, and distributors have 180 days to cease further shipment. Sound like a broken record? This time, the tune has changed a little. On July 16, 2009, FDA approved NDA 22-402, held by Roxane Laboratories, for 15, 30 and 60 mg Codeine Sulfate tablets. So, less than 90 days after the first NDA approval of a widely sold but unapproved product, FDA has taken enforcement action against the other unapproved product manufacturers. This removal will, of course, translate into a real benefit for Roxane who is now the sole supplier of Codeine Sulfate tablets. The relative promptness of FDA’s actions (compared to previous similar situations) should encourage any company who is involved in or considering obtaining approval for a long-marketed but unapproved drug. Often, these products are very well suited to the use of the 505(b)(2) path to approval. As the expert in 505(b)(2) applications, Camargo is available to assist should the need arise.
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