First-Time Generic Approvals: Mobic, Propecia, Zithromax

Yael Waknine

August 08, 2006

August 8, 2006 — The US Food and Drug Administration (FDA) has approved first-time generic formulations for meloxicam 7.5- and 15-mg tablets in the management of osteoarthritis, rheumatoid arthritis, and juvenile rheumatoid arthritis; finasteride 1-mg tablets for the treatment of male pattern hair loss; and azithromycin 100-mg/5-mL and 200-mg/5-mL oral suspension for the treatment of indicated infections.

Generic Meloxicam 7.5- and 15-mg Tablets (Mobic) for Arthritic Symptoms

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.

Generic Finasteride 1-mg Tablets (Propecia) for Male Pattern Hair Loss

On July 28, the FDA approved a first-time generic formulation for finasteride 1-mg tablets (made by Dr. Reddy's Laboratories, Ltd; brand name Propecia, made by Merck & Co, Inc).

Finasteride is indicated for the treatment of androgenetic alopecia in men only. Its clinical safety and efficacy have been demonstrated in men aged 18 to 41 years with mild to moderate hair loss of the vertex and anterior mid-scalp areas.

Generic Azithromycin Oral Suspension (Zithromax) for Indicated Infections

On July 5, the FDA approved first-time generic formulations for azithromycin 100-mg/5-mL and 200-mg/5-mL oral suspension (made by Pliva, Inc; brand name Zithromax, made by Pfizer, Inc).

Azithromycin for oral suspension may be taken with or without food. Pediatric indications include acute otitis media, acute bacterial sinusitis, community-acquired pneumonia (CAP), and pharyngitis/tonsillitis.

Adult indications include CAP; pharyngitis/tonsillitis; skin/skin structure infections; acute bacterial exacerbations of chronic obstructive pulmonary disease; acute bacterial sinusitis; genital ulcer disease in men; and nongonococcal and gonococcal urethritis and cervicitis.

Generic formulations were previously approved for azithromycin 500-mg/vial injection and 250-, 500-, and 600-mg tablets.


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