Orchid Receives Tentative FDA Approval For Memantine Tablets

Chennai-based Orchid Chemicals & Pharmaceuticals has received atentative approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (NDA) for Memantine Hydrochloride tablets in 5mg and 10mg strengths.

Memantine Hydrochloride tablets are indicated for the treatment of Alzheimer’s disease. The tablets are a generic version of Forest Laboratories’ Nameda 5mg and 10mg. The product is under patent litigation between Orchid and Forest, for which the Orchid has a first-to-file certification.

The tablets also contain the following inactive ingredients: microcrystalline cellulose/colloidal silicon dioxide, talc, croscarmellose sodium, and magnesium stearate.

The company has submitted to BSE a copy of the press release dated January 08, 2010 titled, ‘Orchid receives Tentative US FDA nod for Memantine Tablets’.