Indoco Remedies has received final approval of its Abbreviated New Drug Application (ANDA) for Lacosamide Oral Solution USP, 10 mg/mL, to market, a generic equivalent to the reference listed drug (RLD), Vimpat Oral Solution, 10 mg/mL, of UCB, Inc. (UCB), from USFDA. 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. (UCB).
Lacosamide Oral Solution USP, will be manufactured by Indoco Remedies, at their manufacturing facility located at L-14, Verna Industrial Area, Verna, Goa. 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.
Indoco Remedies is engaged in the manufacturing and marketing of formulations (finished dosage forms) and active pharmaceutical ingredients (APIs) in India.
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| Cipla | 1238.30 |
| Zydus Lifesciences | 942.55 |
| Lupin | 2324.25 |
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