Zydus Lifesciences arm bags USFDA approval for schizophrenia drug Brexpiprazole
The drug will be manufactured at the group’s formulation manufacturing facility at Ahmedabad SEZ, India.
Ahmedabad: Zydus Lifesciences Limited’s (formerly known as Cadila Healthcare Limited) subsidiary Zydus Worldwide DMCC (Zydus) has received final approval from the United States Food and Drug Administration (USFDA) to market Brexpiprazole Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg (USRLD: REXULTI tablets).
Brexpiprazole is an atypical antipsychotic indicated for use as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults. It is also indicated for the treatment of schizophrenia in adults and pediatric patients ages 13 years and older.
"Zydus was one of the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification for Brexpiprazole Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg and therefore is eligible for 180 days of shared generic drug exclusivity for Brexpiprazole Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg," the release stated.
The drug will be manufactured at the group’s formulation manufacturing facility at Ahmedabad SEZ, India.
Brexpiprazole tablets had annual sales of USD 1,548 million in the United States according to IQVIA data (IQVIA MAT Sept. 2022). The group now has 340 approvals and has so far filed over 431* ANDAs since the commencement of the filing process in FY 2003-04.
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Zydus group is headquartered in Ahmedabad, India. The group has manufacturing sites and research facilities spread across five states of Gujarat, Maharashtra, Goa, Himachal Pradesh and Sikkim in India and in the US and Brazil.
Zydus’ global business has a strong presence in the regulated markets of the US, Europe (France and Spain) and in the high profile markets of Latin America and South Africa. It is also present in a big way in 25 other emerging markets worldwide.
The group has manufacturing capabilities across the entire pharmaceutical value chain: including formulations, APIs, vaccines, biosimilars, complex products (transdermals, topical etc.), animal health products and wellness products.
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