FDA approves Sun Pharma's generic Clarinex ANDA

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Sun Pharmaceutical Industries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE:SUNPHARMA, BSE: 524715) announced that USFDA has granted it an approval for its Abbreviated New Drug Application (ANDA) to market a generic version of Schering Plough's Clarinex® tablets, 5 mg.

These generic Clarinex tablets contain desloratidine 5 mg and are therapeutically equivalent to Schering Plough's Clarinex tablets 5mg.

Generic Clarinex tablets are indicated in the treatment of seasonal allergic rhinitis, perennial allergic rhinitis and Chronic idiopathic urticaria.

This strength of Clarinex® has annual sales of approximately $212 million in the US.

Source:

Sun Pharmaceutical Industries Ltd.

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