Amneal Pharmaceuticals Receives US FDA Approval for Three Generic Prescription Drugs; Two Using New FDA Electronic Filing Format
Posted AtBio-medicine.org
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 |
