Subscribe to our Newsletters !!
The nipah virus (NiV), a zoonotic virus, can infec
Test tubes are kept in a test tube holder. When th
The male reproductive system ejaculates semen, a t
Participants in clinical trials are volunteers hel
Extrasensory perception (ESP) is perception that o
Fermentation definition: fermentation is an anaero
The field of drug analysis encompasses various com
Alembic Pharmaceuticals Limited (Alembic) today announced that it has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Brexpiprazole Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Rexulti Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg, of Otsuka Pharmaceutical Co., Limited (Otsuka). 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. Refer to our label for full indication.
Brexpiprazole Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg have an estimated market size of US$ 1.6 billion for twelve months ending Dec 2022 according to IQVIA.
Alembic has a cumulative total of 184 ANDA approvals (160 final approvals and 24 tentative approvals) from USFDA.
