Last Updated on December 31, 2023 by The Health Master
Alembic Pharmaceuticals today received tentative approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Vortioxetine tablets of 5 mg, 10 mg, 15 mg, and 20 mg.
The tentatively approved ANDA is therapeutically equivalent to the Reference Listed Drug (RLD) product Trintellix tablets, 5 mg, 10 mg, 15 mg, and 20 mg of Takeda Pharmaceuticals, the company said via a statement.
Vortioxetine tablets are indicated for the treatment of Major Depressive Disorder (MDD), and have an estimated market size of $1249 million for the twelve months ending September 2021, according to IQVIA, it added.
The statement further stated that Alembic is currently in litigation with H. Lundbeck in the Court of Appeals for the Federal Circuit and that the launch of the product will depend on the litigation outcome.
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