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
Medscape Medical News © 2005 Medscape
Cite this: Yael Waknine. First-Time Generic Approvals: New Doses of Tapazole, Monodox, Mestinon - Medscape - Aug 09, 2005.
Comments