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Taj Pharmaceuticals bags US FDA approval for generic Topiramate Tablets

Mumbai : Drug firm Taj Pharmaceuticals today said it has received tentative approval from US health regulator to sell a generic version of Topiramate 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 Topiramate Tablets in 25/50/100mg strength, Taj Pharmaceuticalsceutical Industries said in a statement.

Topiramate 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 25/50/100mg, 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 Taj Pharmaceuticals today closed at Rs 876.50 on Bombay Stock Exchange, up 4.07 per cent from its previous close.

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