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Barr Pharmaceuticals will have to wait until May to get an FDA decision on whether the firm’s emergency contraceptive Plan B (synthetic progestin levonorgestrel) will receive OTC status.
Overall prescription drug sales in the U.S. grew 11.5 percent to $216.4 billion last year despite challenges from new OTC products, concerns about hormone replacement therapies and the reimportation of drugs from Canada, according to IMS Health.
The FDA has delayed issuing a decision on whether to approve OTC status for the emergency contraceptive Plan B (synthetic progestin levonorgestrel) so that it can review additional data submitted by Barr Pharmaceuticals and the Women’s Capital Corporation (WCC).