Alembic Pharmaceuticals receives USFDA final approval for Lamotrigine Extended-Release Tablets
Lamotrigine extended-release tablets are indicated for adjunctive therapy for primary generalized tonic-clonic seizures and partial-onset seizures
Lamotrigine extended-release tablets are indicated for adjunctive therapy for primary generalized tonic-clonic seizures and partial-onset seizures
The product is expected to be launched in Q3FY25
Enzalutamide Tablets will be produced at the Group’s manufacturing site at SEZ, Ahmedabad
Enzalutamide Capsules will be produced at the Group’s manufacturing site at Moraiya, Ahmedabad
Paliperidone extended-release tablets are an atypical antipsychotic agent indicated for treatment of schizophrenia
The product is an additional formulation of Cresemba Capsule 100 mg and Cresemba Intravenous Infusion 200 mg
MVA-BN approved for use against mpox and smallpox in adolescents 12-17 years of age after expedited review with EMA
New indication supported by the MANDARA trial which showed nearly 60% of patients achieved remission and 41% of patients fully stopped taking oral corticosteroids
This approval is backed by a decade of proven safety and efficacy data of Ocrevus® IV, with over 350,000 people treated globally
Bumetanide Injection USP (RLD Bumex) had estimated annual sales of USD 20 million in the U.S.
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