FDA approves three Amneal generics

PETERSON, N.J. Amneal Pharmaceuticals recently received approval from the Food and Drug Administration to manufacture three generic drugs: Primidone 50 mg and 250 mg, Cyclobenzaprine 10 mg, and Demeclocycline 150 mg and 300 mg.

Demeclocycline is the generic of Stonebridge Pharma’s Declomycin, which is used to treat infections caused by susceptible strains in conditions like Rocky Mountain spotted fever and respiratory tract infections. Primidone is the generic of Valeant Pharmaceuticals Mysoline, used to treat epileptic seizures. Cyclobenzaprine is the generic of the muscle spasm relief medication Flexeril by McNeil Consumer Healthcare.

These three products are the company’s 15th, 16th and 17th application approvals.