New product approvals for Zydus Cadila from USFDA

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Zydus Cadila has received three product approvals from the USFDA in quick succession. The group has received approvals to market Benzonatate Tablets 100 and 200 mg, Naproxen Tablets and tentative approval for Amlodipine Besylate Tablets 2.5, 5 and 10 mg.

The branded sales in the US market of Benzonatate Tablets, which falls in the cough-suppresant segment, was estimated at USD 134 million in 2006 as per NDC. The branded sales of Amlodipine Besylate Tablets, an anti-hypertensive, was estimated at USD 2.74 billion in 2006 and that of Naproxen Tablets, which falls in the analgesic segment, was estimated at USD 0.67 billion in 2006 as per NDC Health.

The group will market all three drugs through its US subsidiary Zydus Pharmaceuticals (USA) Inc . The group now has 27 approvals since the commencement of filing process in FY 2003-04. So far, the group has filed 60 ANDAs and 51 DMFs.

 

Sourced From: Pressman India