First-Time Generic Approvals: New Doses of Tapazole, Monodox, Mestinon

Yael Waknine

August 09, 2005

Aug. 9, 2005 -- The U.S. Food and Drug Administration (FDA) has approved first-time generic formulations and dosage strengths of methimazole 15-mg tablets, U.S. Pharmacopeia, for the treatment of hyperthyroidism; doxycycline monohydrate 150-mg tablets for the treatment of infections caused by susceptible strains of Gram-positive and Gram-negative microorganisms; and pyridostigmine bromide 30-mg tablets for the treatment of myasthenia gravis.

First-Time 15-mg Dose of Generic Methimazole Tablets (Tapazole) for Hyperthyroidism

On July 12, the FDA approved a first-time generic formulation and first-time 15-mg dosage strength of methimazole tablets, U.S. Pharmacopeia (made by Cedar Pharmaceuticals, LLC). Methimazole tablets were previously approved in 5- and 10-mg dosage strengths (Tapazole, made by AAI Pharma and distributed by King Pharmaceuticals, Inc.).

Methimazole tablets are indicated for the treatment of hyperthyroidism in adult and pediatric patients.

First-Time 150-mg Dose of Generic Doxycycline Tablets (Monodox Capsules) for Certain Infections

On July 14, the FDA approved a first-time generic formulation and first-time 150-mg dosage strength of doxycycline monohydrate tablets (made by Par Pharmaceutical, Inc.). Doxycycline was previously approved in 50- and 100-mg capsule strengths (brand name Monodox, made by Watson Laboratories, Inc.).

Doxycycline monohydrate is a tetracycline antibiotic indicated for the treatment of infections caused by susceptible strains of Gram-positive and Gram-negative microorganisms.

First-Time 30-mg Dose of Generic Pyridostigmine Bromide Tablets (Mestinon) for Myasthenia Gravis

On July 20, the FDA approved a first-time generic formulation and first-time 30-mg dosage strength of pyridostigmine bromide tablets, U.S. Pharmacopeia (made by Barr Laboratories, Inc.).

Pyridostigmine bromide was previously approved in 60-mg tablet and 180-mg extended-release tablet strengths (Mestinon, made by Valeant Pharmaceuticals International), in addition to a 30-mg tablet strength that was discontinued for reasons not pertaining to safety or efficacy.

Pyridostigmine bromide tablets are indicated for the treatment of myasthenia gravis.

Reviewed by Gary D. Vogin, MD

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