Amneal Pharmaceuticals Receives US FDA Approval for Three Generic Prescription Drugs
Posted on: Wednesday, 7 May 2008, 15:00 CDT
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.
Amneal Pharmaceuticals LLC
CONTACT: Jim Luce, Executive Vice President-Sales & Marketing of AmnealPharmaceuticals, LLC, +1-949-610-8018, Mobile, +1-949-633-2293, or Fax,+1-949-610-8218, jim@amneal.com
Web site: http://www.amneal.com/
Source: PRNewswire
Related Articles
- Jim Cyze Promoted to Chief Executive Officer (CEO) and President of Production Service Associates, LLC
- Gammon Gold Confirms Q2 As Another Consecutive Quarter of Record Key Performance Indicators Including Record Production of 71,154 Gold Equivalent Ounces and Operating Cash Flow of $25. 3 Million
- TE Products Pipeline Company, LLC Exercises Its Call Option to Redeem Its 7.51% Senior Notes, Due 2028
- Cubist Pharmaceuticals' CUBICIN Approved for Additional Indications in the EU
- Teva Receives First U.S. Approval of Generic Zocor(R) Tablets; Product to Be Shipped Immediately
- Lannett Company Receives Approval for Probenecid Tablets 500 Mg, USP
- GrayHair Software Launches USPS R2006 Rate Comparison Service
- Wyeth Signs Three Biotech Product Deals: The Agreements Were an Indicator of the Direction That Major Pharmaceutical Companies Are Heading
- Taro Receives Approval for Hydrocortisone Butyrate Cream USP, 0.1% ANDA; Generic Equivalent to Locoid(R) Cream
- Heart Rates Can Indicate Risk of Sudden Heart Death: Study
 |
 |
User Comments (0)
RSS Feeds