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Several Drug Products Not Withdrawn for S&E

10/31/2014

Federal Register Notice: FDA has determined that several drug products were not withdrawn from sale for reasons of safety or effectiveness. This determination means that the agency will not begin procedures to withdraw approval of ANDAs that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements. These products are: Taro Pharma’s Topicort (desoximetasone), Hoffmann La Roche’s Kytril, Leo Pharma’s Dovonex, Allergan’s Lumigan, Wyeth’s Lybrel, and Bedford Laboratories’ Ketorolac Tromethamine injectable. To view this notice, click here.

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