Sun Pharmaceutical gets tentative US FDA approval for Alzheimer’s treatment
10 Apr 2010
Sun Pharmaceutical Industries Ltd, one of India's largest generic drug maker said today that the US Food and Drug Administration (FDA) has granted its subsidiary a tentative approval to market a generic version of Forest Laboratories' Namenda tablets.
These generic memantine tablets are equivalent to Forest Laboratories' Namenda tablets and include two strengths of 5 mg and 10 mg, the company said in a statement today.
These strengths of memantine have a combined annual sale of approximately $1.2 billion in the US.
Memantine tablets are indicated for the treatment of moderate to severe Alzheimer's disease.
Last month, the FDA approved its abridged new drug application (ANDA) for `Promethazine Hydrochloride' and `Codeine Phosphate Oral Syrup', 6.25 mg/5 ml and 10mg/5ml, respectively. (See: Sun Pharma gets USFDA approval for generic Prometh syrup)
This medication is used to treat symptoms caused by the common cold, flu, allergies, or other breathing Illnesses such as sinusitis, bronchitis.
This medication has annual sales of approximately $16 million in the US.
