Lupin schizophrenia drug Aripiprazole gets USFDA okay
Aripiprazole Tablets USP 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.
Mumbai: Global pharma major Lupin Limited has announced that the Company has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Aripiprazole Tablets USP, 2 mg, 5 mg, 10 mg,15 mg, 20 mg and 30 mg, to market a generic equivalent of Abilify Tablets, 2 mg, 5 mg, 10 mg, 15 mg, 20 mg and 30 mg, of Otsuka Pharmaceutical Company, Ltd.
The product will be manufactured at Lupin’s Pithampur facility in India.
Aripiprazole Tablets USP 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.
Aripiprazole Tablets USP (RLD Abilify) had estimated annual sales of USD 107 million in the U.S. (IQVIA MAT January 2024).
Medical Dialogues team had earlier reported that Lupin had announced the launch of Lurasidone Hydrochloride Tablets, 20 mg, 40 mg, 60 mg, 80 mg and 120 mg in the United States.
Read also: Lupin names Christoph Funke as Chief Technical Operations Officer
Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.
The Company specializes in the cardiovascular, anti-diabetic, and respiratory segments and has a significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS), and women’s health areas. The company invested 7.9% of its revenue in research and development in FY23.
Lupin has 15 manufacturing sites, 7 research centers.
Read also: Lupin gets USFDA nod to market a generic drug to treat bacterial infections
