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Orchid gets tentative US FDA nod for memantine tablets
Our Bureau, Mumbai | Friday, January 8, 2010, 08:00 Hrs  [IST]

The Chennai-based global pharma major, Orchid Chemicals & Pharmaceuticals Ltd has received tentative approval from the US Food and Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA) for generic drug memantine hydrochloride tablets in 5 mg and 10 mg strengths. Orchid’s product is determined to be the generic equivalent of Forest Laboratories’ Namenda 5 mg and 10 mg.

Memantine is prescribed for the treatment of Alzheimer's disease. Orchid filed its ANDA for this product under the Paragraph IV, First-to-file (FTF) certification. The product is under patent litigation between Orchid and Forest. According to IMS, the market for memantine tablets is around US$ 1.1 billion.

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