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Suppliers keep expanding scope of lines.

NEW YORK--Amneal Pharmaceuticals has received Food and Drug Administration approval for three generic drugs, two using the agency's new electronic filing format.

The company received the agency's O.K. to manufacture primidone tablets (50/250 mg), cyclobenzaprine tablets (10 mg) and demeclocycline tablets (150/300 mg).

Demeclocycline HCI tablets USE in strengths of 150 mg and 300 mg, are an AB-rated, therapeutically equivalent alternative to Declomycin (Stonebridge Pharma) and are indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in several conditions, including Rocky Mountain spotted fever and respiratory tract infections.

Primidone tablets USR 50 and 250 rag, are an AB-rated, therapeutically equivalent alternative to Mysoline (Valeant Pharmaceuticals). Used alone or with other anticonvulsants, they are indicated for the control of grand mal, psychomotor and focal epileptic seizures and may control grand mal seizures refractory to other anticonvulsant therapy.

Cyclobenzaprine HC1 tablets USR 10 mg, are an AB-rated therapeutically equivalent alternative to Flexeril (McNeil Consumer Healthcare) and are indicated as an adjunct to rest and physical therapy for relief of muscle spasms associated with acute, painful musculoskeletal conditions.

The three products are Amneal's 15th, 16th and 17th abbreviated new drug application approvals (ANDAs). All three are shipping and will be sold directly to the trade as well as through wholesalers/distributors.

Separately, Glenmark Generics, a subsidiary of Glenmark Pharmaceuticals, has received ANDA approvals for mometasone furoate ointment USP (0.1%), mometasone furoate cream USP (0.1%) and metformin hydrochloride tablets USP (500, 850 and 1,000 mg).

Hi-Tech Pharmacal Co. has launched an authorized generic version of Warner Chilcott Ltd.'s Dovonex scalp solution. The product is indicated for treating psoriasis of the scalp. Citing figures from IMS Health, Hi-Tech registered sales last year of about $18 million.

KV Pharmaceutical Co. has announced approval of the 50-mg strength of a generic version of Toprol-XL (AstraZeneca PLC). The metoprolol succinate extended-relief tablets are indicated for the treatment of hypertension. KV says it now offers all four dosage strengths, and that the newest sells the most in terms of unit and dollar volume.

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Title Annotation:RX/Generic Drugs; Amneal Pharmaceuticals receives Food and Drug Administration approval for three generic drugs
Publication:Chain Drug Review
Geographic Code:1USA
Date:Jun 30, 2008
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