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Endocrine Disorders
Methylprednisolone Sodium Succinate approved by FDA
September 5th, 2004
American Pharmaceutical Partners, Inc., (APP, APPX) announced that it has received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Methylprednisolone Sodium Succinate for Injection USP, 40 mg (base)/vial and 125 mg (base)/vial, the generic equivalent of Pfizer's Solu-Medrol and Abbott Laboratories' A-Methapred. Sales of the product totaled $54 million in 2003. Methylprednisolone Sodium Succinate brings to 10 the number of product approvals, nine abbreviated new drug applications (ANDAs) (including a final product approval for which the company previously received a tentative approval) and one NDA approval for...
Source: Medical Letter on the CDC & FDA (2004-09-05)
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