Biocon Pharma Limited 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 available in 23.75 mg/95 mg, 36.25 mg/145 mg, 48.75 mg/195 mg, and 61.25 mg/245 mg strengths. They are indicated for treating Parkinson’s disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide or manganese intoxication.
US FDA Approval Received
Biocon Pharma Limited, a subsidiary of the Company, announced it has received tentative approval from the U.S. Food and Drug Administration (U.S. FDA) for its ANDA relating to Carbidopa and Levodopa Extended-Release Capsules. This approval represents a significant regulatory milestone for the pharmaceutical company.
Dosage Strengths and Indication
The Carbidopa and Levodopa Extended-Release Capsules will be available in various strengths, including 23.75 mg/95 mg, 36.25 mg/145 mg, 48.75 mg/195 mg, and 61.25 mg/245 mg. These capsules are specifically indicated for the treatment of Parkinson’s disease, post-encephalitic parkinsonism, and parkinsonism resulting from carbon monoxide or manganese intoxication, thus addressing a significant medical need.
Source: BSE
