Biocon arm gets tentative FDA nod for Parkinson's treatment capsules carbidopa–levodopa

Biotechnology firm Biocon Ltd on Friday (December 5) said its wholly-owned subsidiary, Biocon Pharma Ltd, has received tentative approval from the US Food and Drug Administration for its abbreviated new

drug application for carbidopa and levodopa extended-release capsules.

The approval covers all four strengths submitted by the company: 23.75 mg/95 mg, 36.25 mg/145 mg, 48.75 mg/195 mg, and 61.25 mg/245 mg.

According to Biocon, 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.

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This week, Biocon said its board of directors will meet on Saturday (December 6) to review two key proposals related to its unlisted material subsidiary Biocon Biologics Limited and the company’s future capital requirements.

The board will examine a proposal for investment in Biocon Biologics Ltd (BBL) through the purchase or acquisition of securities from existing shareholders of BBL. The consideration may involve cash and/or non-cash components.

As part of the transaction structure, Biocon may issue and allot fully paid-up equity shares on a preferential allotment basis through private placement to the shareholders of BBL.

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The second item on the agenda covers a broader capital-raising plan. The board will evaluate raising funds through the issuance of commercial paper via private placement and/or equity shares or other eligible securities.

Shares of Biocon Ltd ended at ₹392.80, up by ₹4.55, or 1.17%, on the BSE today, December 5.