Lupin obtains FDA nod for generic Abilify
Aripiprazole Tablets are indicated for the treatment of schizophrenia and the acute treatment of manic and mixed episodes associated with bipolar I disorder.
Lupin has received the Food and Drug Administration’s clearance for Aripiprazole Tablets, 2 mg, 5 mg, 10 mg,15 mg, 20 mg and 30 mg, which is the generic of Otsuka’s Abilify.
The product will be manufactured at Lupin’s Pithampur facility in India.
Aripiprazole Tablets are indicated for the treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder, adjunctive treatment of major depressive disorder, irritability associated with autistic disorder and treatment of Tourette’s disorder.
[Read more: Lupin obtains FDA OK for generic Vibramycin]
Aripiprazole tablets had a market value of $107 million, per IQVIA January 2024 data.