The Alembic Pharmaceuticals share price gained 1.3 percent in early trade on March 9 as company received tentative approval from the USFDA for tablets used in treatment of major depressive disorder.
Alembic Pharmaceuticals has received tentative approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Brexpiprazole Tablets, 0.25mg, 0.5mg, 1mg, 2mg, 3mg and 4mg, the company said in its press release.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Rexulti Tablets, 0.25mg, 0.5mg, 1mg, 2mg, 3mg and 4mg, of Otsuka Pharmaceutical Co Limited (Otsuka).
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Brexpiprazole tablets are indicated as an adjunctive therapy to antidepressants for the treatment of major depressive disorder and for treatment of schizophrenia.
It may not be indicated for certain other uses due to unexpired exclusivities for the RLD for such uses.
Brexpiprazole tablets have an estimated market size of $1.6 billion for twelve months ending December 2022 according to IQVIA.
Alembic has a cumulative total of 184 ANDA approvals (160 final approvals and 24 tentative approvals) from USFDA.
At 9:16am, Alembic Pharmaceuticals was quoting at Rs 519.05, up Rs 6.75, or 1.32 percent on the BSE.
On March 8, the company received a final approval from the USFDA for its ANDA Prazosin Hydrochloride Capsules USP for the treatment of hypertension, to lower blood pressure.