First-Time Generic Approvals: Mobic, Proscar, Zithromax

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First-Time Generic Approvals: Mobic, Proscar, Zithromax

Yael Waknine

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;

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 (Proscar) 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 Laboratories, 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.

http://www.medscape.com/viewarticle/542463