Biocon Pharma Receives Tentative Approval from US FDA for Carbidopa and Levodopa Extended-Release Capsules

Biocon Pharma Limited, a wholly owned subsidiary of Biocon Ltd, has announced that it 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. The capsules are indicated for the treatment of Parkinson’s disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication or manganese intoxication. The strengths approved are 23.75 mg/95 mg, 36.25 mg/145 mg, 48.75 mg/195 mg, and 61.25 mg/245 mg.