Alembic Pharmaceuticals Ltd announced on Friday that it had received interim approval from the US health regulator for its generic vortioxetine tablets indicated for the treatment of major depressive disorder.
The interim approval granted by the United States Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for vortioxetine 5 mg, 10 mg, 15 mg and 20 mg tablets, indicated the company in a press release.
These are therapeutically equivalent to the Reference Drug Product (RLD) 5 mg, 10 mg, 15 mg and 20 mg Trintellix tablets from Takeda Pharmaceuticals, USA, Inc, he added.
Citing data from IQVIA, the company said that these vortioxetine tablets have an estimated market size of $ 1,249 million for a twelve-month period ending in September 2021.
Alembic, however, said he is currently in litigation with H Lundbeck in the Federal Circuit Court of Appeals and that the product launch will depend on the outcome of the litigation.
“Our ANDA may not be listed for some uses due to unexpired RLD exclusives for such uses,” the company said.
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