Chennai, Jan 8 (Inditop.com) The city based Orchid Chemicals & Pharmaceuticals Friday said it has received tentative approval from US Food and Drug Administration (USFDA) for its drug to treat Alzheimer’s disease.
According to Orchid, the approval is for the 5mg and 10mg memantine hydrochloride tablets, which are determined to be generic equivalent of Forest Laboratories’ Namenda tablets of similar strength.
Memantine is prescribed for the treatment of Alzheimer’s disease.
Orchid filed its abbreviated new drug application (ANDA) for this product under the Paragraph IV, First-to-file (FTF) certification. The product is under patent litigation between Orchid and Forest. The market size for memantine tablets is estimated to be around $1.1 billion.
