Par Megace ES
This article was originally published in Pharmaceutical Approvals Monthly
Par continues to plan a summer launch of its megestrol formulation Megace ES despite FDA's recent three-month extension of its original user fee goal date of April 29, the firm says April 18. "The extension results from Par's recent submission, at the FDA's request, of existing supplemental data on Megace ES," Par said. The company's 505(b)(2) NDA seeks claims for treatment of anorexia, cachexia, or any unexplained, significant weight loss in AIDS patients...
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