Orchid receives tentative FDA approval for Alzheimer’s drug Memantine tablet
08 Jan 2010
Chennai-based Orchid Chemicals & Pharmaceuticals has received tentative approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) Memantine Hydrochloride tablets in 5 mg and 10mg strengths, the company said in a filing with the Bombay Stock Exchange.
Memantine, which is prescribed for the treatment of Alzheimer's disease is determined to be the generic equivalent of Forest Laboratories' Namenda 5mg and 10 mg.
Orchid filled 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 $ 1.1 billion.
The company recently said it had purchased $19.78 million foreign currency convertible bonds (FCCBs) to help reduce its liabilities and interest costs and said it is in the process of extinguishing such bonds.