Wednesday, May 7, 2008

Amneal Pharmaceuticals Receives US FDA Approval for Three Generic Prescription Drugs; Two Using New FDA Electronic Filing Format

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.

The details for this can be read here

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