FDA APPROVES BEDFORD LABS' GENERIC SOLU-MEDROL

Bedford Laboratories has received FDA approval for its abbreviated new drug application for methylprednisolone sodium succinate for injection. This product is the generic equivalent to Pfizer's Solu-Medrol.

Methylprednisolone is an adrenocorticosteriod hormone with multiple indications, including endocrine disorders, rheumatic disorders, collagen diseases, dermatologic diseases, gastrointestinal diseases, allergic states, ophthalmic diseases and neoplastic diseases, according to Bedford.

Bedford will produce the drug as a sterile lyophilized powder in four single-dose presentations: 40, 125, 500 and 1,000 mg.

Bedford Laboratories is a division of Ben Venue Laboratories, a subsidiary of Boehringer Ingelheim.