Amneal wins FDA approval for three generic drugs

Demeclocycline HCl tablets USP, in strengths of 150mg and 300mg, is an AB-Rated, therapeutically equivalent alternative to Declomycin (a trademark of Stonebridge Pharma) and is indicated in the treatment of infections caused by susceptible strains of the designated microorganisms in a number of conditions including Rocky Mountain spotted fever and respiratory tract infections.

Primidone tablets USP, in strengths of 50mg and 250mg, an AB-Rated, therapeutically equivalent alternative to Mysoline (a trademark of Valeant Pharmaceuticals) which, used alone or concomitantly with other anticonvulsants, is indicated in the control of grand mal, psychomotor, and focal epileptic seizures. It may control grand mal seizures refractory to other anticonvulsant therapy.

Cyclobenzaprine HCl tablets USP, in 10mg strength, is an AB-Rated therapeutically equivalent alternative to Flexeril (a trademark of McNeil Consumer Healthcare) and is indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. All three products are shipping and will be sold directly to the trade as well as through wholesalers-distributors.