BARR SUBMITS NEW PLAN B APPLICATION

Barr Pharmaceuticals may be only weeks away from FDA approval to sell its controversial contraceptive Plan B OTC after resubmitting its application and apparently meeting all the agency's demands.

The revised application addresses of the FDA's recommended application changes, agency spokeswoman Susan Bro said. In particular, the company provides specific details about its risk management plans for the drug's OTC sale. The FDA is planning to complete its review of the proposal "in a matter of weeks," Bro added. A Barr spokeswoman confirmed that the revised application was sent, but declined to provide further details.

The revised application was submitted in response to the agency's issuing a framework July 31 for the drug's OTC approval. The company met with the FDA Aug. 8 to discuss this plan.

The agency has required a variety of enforcement efforts from Barr's subsidiary, Duramed Pharmaceuticals, including assurances that the drug will be kept behind the counter at pharmacies and dispensed only with production of a valid photo identification establishing the age of the consumer.

The FDA also is requiring that Duramed amend its application for Plan B to change the minimum age for OTC use to 18. The company had originally requested that women 16 and older be able to obtain the drug OTC. (http://www.fdanews.com/did/5_164/)