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Sun Pharma up on getting USFDA approval for Bicalutamide tablets

July 8, 2009

Sun Pharmaceutical Industries has announced that United States Food & Drug Administration (USFDA) has granted its subsidiary an approval for an abbreviated new drug application (ANDA) for generic Casodex, Bicalutamide tablets.

These tablets are an androgen receptor inhibitor indicated for use in combination therapy with a luteinizing hormone-releasing hormone (LHRH) analog for the treatment of Stage D2 metastatic carcinoma of the prostate. Bicalutamide tablets are generic version of Casodex tablets from AstraZeneca, having annual sales of approximately $314 million in the US market.

Recently, the company received a tentative nod from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for the generic version of Optivar, azelastine ophthalmic solution 0.05%. The approval will enable the Indian pharma major to market the drug in the US market.

The sterile azelastine ophthalmic solution is the generic version of Optivar Ophthalmic Solution manufactured by Medpointe Pharmaceuticals, which has annual sales of around $48 million in the US market.

The drug is recommended for the treatment of the itching of the eyes associated with allergic conjunctivitis.

Last month, the USFDA seized drug products manufactured by Caraco Pharmaceutical Laboratories (Caraco) – the US subsidiary of Sun Pharma – at the company’s Michigan facilities in Detroit, Farmington Hills, and Wixom.

According to the FDA, Caraco repeatedly failed to meet current Good Manufacturing Practice (cGMP) requirements, which guarantee the quality of manufactured drugs. Following this action, the company has been asked to instantaneously stop from further distributing drugs until there is assurance that the firm complies with good manufacturing requirements.

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