USFDA30 Jan 2026, 01:16 pm
Indoco Remedies Receives Final ANDA Approval from USFDA for Lacosamide Oral Solution USP, 10mg/mL
AI Summary
Indoco Remedies Ltd. has announced the final approval of their Abbreviated New Drug Application (ANDA) for Lacosamide Oral Solution USP, 10 mg/mL, by the USFDA. This generic equivalent to the reference listed drug, Vimpat Oral Solution, 10 mg/mL, of UCB, Inc., is used to treat partial onset seizures and primary generalized tonic-clonic seizures in adults and children with epilepsy who are at least 4 years old. The product will be manufactured at Indoco's facility in Goa, India. This approval is a testament to Indoco's commitment to delivering high-quality healthcare to patients worldwide.
Key Highlights
- Indoco Remedies receives final ANDA approval from USFDA for Lacosamide Oral Solution USP, 10 mg/mL
- Lacosamide Oral Solution USP, 10 mg/mL, is bioequivalent and therapeutically equivalent to the reference listed drug, Vimpat Oral Solution, 10 mg/mL, of UCB, Inc.
- The product will be manufactured by Indoco Remedies Limited at their facility in Goa, India
- Lacosamide Oral Solution is used to treat partial onset seizures and primary generalized tonic-clonic seizures in adults and children with epilepsy who are at least 4 years old
- This approval further reinforces Indoco's commitment to delivering high-quality healthcare to patients worldwide