Archive · 6 Dec 2025
Biocon gets FDA approval for Parkinson's drug
Biocon, a biotechnology company, announced that its subsidiary, Biocon Pharma, got a tentative approval from the US FDA for a new drug.
This drug, called carbidopa and levodopa extended-release capsules, is used to treat Parkinson’s disease and similar conditions.
The approval covers four different strengths of the drug.
Biocon’s board also decided to fully integrate Biocon Biologics, another subsidiary, by acquiring the remaining stake held by Viatris.
This deal is worth $5.5 billion and is expected to be completed by March 2026.
The company plans to raise about $500 million through a qualified institutional placement.
The company’s shares went up by a small amount on the stock market.
Biocon Pharma received tentative FDA approval for carbidopa and levodopa extended-release capsules.
The approval covers four strengths of the drug for treating Parkinson’s disease and related conditions.
Biocon will fully integrate Biocon Biologics by acquiring Viatris’ remaining stake for $815 million.
The integration deal values Biocon Biologics at $5.5 billion and is expected to complete by March 31, 2026.
Biocon’s board approved raising up to ₹4,500 crore through a qualified institutional placement.
- Who
- Biocon Ltd and its subsidiary Biocon Pharma Ltd
- What
- Received tentative FDA approval for carbidopa and levodopa extended-release capsules and announced the full integration of Biocon Biologics
- When
- December 5-6, 2023
- Where
- United States
- Why
- For the treatment of Parkinson’s disease and related conditions, and to simplify corporate structure and strengthen Biocon Biologics’ strategic and financial flexibility
- Company
- Biocon Ltd
- Subsidiary
- Biocon Pharma Ltd
- Approval Received
- Tentative FDA approval
- Drug
- Carbidopa and Levodopa Extended-Release Capsules
- Strengths Approved
- 23.75 mg/95 mg, 36.25 mg/145 mg, 48.75 mg/195 mg, 61.25 mg/245 mg
- Indications
- Parkinson’s disease, post-encephalitic Parkinsonism, Parkinsonism from carbon monoxide or manganese intoxication
- Board Meeting
- December 6, 2023
- Share Price
- ₹392.80 (up by ₹4.55 or 1.17%)
- Share Swap Price
- ₹405.78 per Biocon share
- Expected Integration Completion
- March 31, 2026
- Fundraising Amount
- ₹4,500 crore (about $500 million)
Sources
Biocon arm gets tentative FDA nod for Parkinson's treatment capsules carbidopa–levodopa
Biocon to merge biologics unit in $5.5 billion deal
Biocon to fully integrate Biocon Biologics; to acquire Viatris’ remaining stake via share swap
Biocon to fully merge Biocon Biologics; board approves fundraise up to Rs 4,500 crore
Biocon integrates Biocon Biologics; to raise ₹4,500 crore via QIP to fund Viatris payout