Drug firm Sun Pharma today said it has received tentative approval from US health regulator to sell a generic version of Rilutek tablets, used in treating central nervous system diseases, in the American market.
The Mumbai-based firm has received a tentative approval for Abbreviated New Drug Application (ANDA) for a generic version of Rilutek tablets in 50 mg strength, Sun Pharmaceutical Industries said in a statement.
Rilutek tablets, a Sanofi Aventis product, has annual sales of nearly $50 million in the United States. The generic version of the tablets contain Riluzole Hydrochloride in the strength of 50 mg, it said.
Riluzole Hydrochloride tablets are indicated in the treatment of amyotrophic lateral sclerosis (ALS). ALS is a disease of the central nervous system that affects a person's ability to move certain muscles.
Shares of Sun Pharma today closed at Rs 1968.50 on Bombay Stock Exchange, up 1.07 per cent from its previous close.