Alembic Pharmaceuticals receives USFDA approval for Lamotrigine Orally Disintegrating Tablets
India, Feb. 26 -- Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Lamotrigine Orally Disintegrating Tablets USP, 25 mg, 50 mg, 100 mg and 200 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Lamictal ODT Orally Disintegrating Tablets, 25 mg, 50 mg, 100 mg, and 200 mg, of GlaxoSmithKline LLC.Lamotrigine is indicated as adjunctive therapy in patients aged 2 years and older for: i) partial-onset seizures, ii) primary generalized tonic-clonic (PGTC) seizures, and iii) generalized seizures of Lennox Gastaut syndrome. It is also indicated for conversion to monotherapy in adults (aged 16 years and older)...
To read the full article or to get the complete feed from this publication, please
Contact Us.