Drug Approval | March 21, 2022
Alembic Pharmaceuticals receives USFDA approval for Lacosamide tablets
The tablets are indicated for the treatment of partial-onset seizures in patients 4 years of age and older
The tablets are indicated for the treatment of partial-onset seizures in patients 4 years of age and older
The US business faced price erosion due to increased competition.
With over 30 years of pharmaceutical industry experience, Ponnusamy will lead Alembic’s animal health business strategy, market expansion, and operational growth initiatives
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Gilenya Capsules, 0.5 mg of Novartis Pharmaceuticals Corporation (Novartis)
In his new role, he is expected to further strengthen Zenex Animal Health’s market position and accelerate its next phase of growth.
In just the last few days, companies including Lupin, Biocon, Alembic Pharmaceuticals and Aurobindo Pharma have announced approvals for 5 mg and 10 mg tablets, all bioequivalent to Farxiga
Final approval for diabetes and heart-failure drug opens access to a $10.5 billion US market opportunity, with shared exclusivity benefits.
Paroxetine extended-release tablets are indicated for the treatment of major depressive disorder
Pivya is Alembic’s first branded pharmaceutica product in the US and is being marketed through Alembic Therapeutics LLC
The approved product is a generic version of the reference listed drug (RLD) Lamictal ODT by GlaxoSmithKline and is indicated for the treatment of epilepsy and bipolar disorder
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