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Biocon Pharma Limited Secures U.S. FDA Tentative Approval for Carbidopa and Levodopa Extended-Release Capsules

  • Posted by: BIOCON

NOTIFICATION TO STOCK EXCHANGE

COMPANY STATEMENT

This is to inform you that Biocon Pharma Limited, a wholly owned subsidiary of the Company, has received tentative approval from the U.S Food and Drug Administration (U.S. FDA) for its ANDA for Carbidopa and Levodopa Extended-Release Capsules, in 23.75 mg/95 mg, 36.25 mg/145 mg, 48.75 mg/195 mg, and 61.25 mg/245 mg strengths. Carbidopa and Levodopa Extended-Release Capsules are indicated for the treatment of Parkinson’s disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication or manganese intoxication.

Author: BIOCON
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