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On July 19, the FDA approved 13 first-time generic formulations for meloxicam 7.5- and 15-mg tablets (brand name Mobic, made by Boehringer Ingelheim Pharmaceuticals, Inc).

The generic tablets will be manufactured by Breckenridge Pharmaceutical, Inc; CorePharma LLC; Caraco Pharmaceutical Laboratories, Ltd; Lupin Ltd; Mylan Pharmaceuticals, Inc; Watson Laboratories, Inc; Zydus Pharmaceuticals USA, Inc; Roxane Laboratories, Inc; Teva Pharmaceuticals, USA; Glenmark Pharmaceuticals, Ltd; Par Pharmaceutical; Mutual Pharmaceutical Company, Inc; Actavis Totowa, LLC; and Genpharm, Inc).

According to an FDA news release, the meloxicam approval was the result of a “cluster” review approach, one of the process improvements instituted in the Office of Generic Drugs (OGD).

Because the OGD often receives multiple applications from different sponsors when the 5-year new chemical entity exclusivity for a drug expires, concomitant reviews can increase efficiency and save time.

In the case of meloxicam, 13 of 20 submitted generic drug applications were approved after approximately 9 months of review.

Meloxicam tablets are indicated for the relief of signs and symptoms of osteoarthritis and rheumatoid arthritis. They may also be used to relieve signs and symptoms of pauciarticular or polyarticular juvenile rheumatoid arthritis in patients aged 2 years and older.

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