Amneal Pharmaceuticals Receives US FDA Approval for Three Generic Prescription Drugs; Two Using New FDA Electronic Filing Format
PATERSON, N.J., May 7 /PRNewswire/ -- Amneal Pharmaceuticals is pleased to announce that it received US FDA approval to manufacture Primidone Tablets (50/250mg), Cyclobenzaprine Tablets (10mg) and Demeclocycline Tablets (150/300mg) within the last several weeks. Two of these products were filed during 2007 using the FDA's evolutionary eCTD/QbR/QOS format that enabled approvals in less than twelve months.
Demeclocycline HCl Tablets USP, in strengths of 150mg and 300mg, is an AB-Rated, therapeutically equivalent alternative to Declomycin(R) (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(R) (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(R) (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.
These three products are Amneal's 15th, 16th and 17th ANDA (Abbreviated New Drug Application) approvals and continues to build the momentum for the aggressive growth Amneal has designed and is experiencing. All three products are shipping and will be sold directly to the trade as well as through wholesalers-distributors.
Separately, in December 2007 Amneal closed on the acquisition of a 30,000 sq ft liquid Rx manufacturing plant in New Jersey, completed construction on a 74,000 sq ft R&D Centre in India in February and, at the end of April, announced the execution of an asset purchase agreement to acquire Interpharm Holdings.
Amneal Pharmaceuticals LLC, headquartered in Paterson, NJ, is a USA-based firm that develops, manufacturers and distributes generic pharmaceutical products regulated and approved by the US FDA. Positioned as "Generic's New Generation," the company utilizes diverse R&D and manufacturing expertise to conceive breakthrough developments with lasting impact. Vigorous ANDA growth and broad product acquisitions are key features of Amneal's strategic growth plan, as is the company's commitment to building deep relationships with its customer base. Amneal delivers superior service levels, quality products, and dynamic value throughout the pharmaceutical industry.
June 27, 2008