April 19, 2024 03:41 (IST)
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Two Aurobindo Pharma products receive USFDA approval
Hyderabad/Mumbai, Apr 1 (IBNS) Aurobindo Pharma Limited announced on Friday that it has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Valganciclovir Tablets USP, 450 mg; and Vancomycin Hydrochloride for Injection USP, 500 mg/vial and 1 g/vial.
The company said that the Valganciclovir Tablet is to be launched in Q1 FY16-17 and the Vancomycin Hydrochloride for Injection in the later part of the same fiscal year.
Valganciclovir tablets is an anti-viral used in the treatment of Cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome and prevention of CMV disease in kidney, heart or kidney-pancreas transplant patients.
The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Valcyte of Hoffman-La Roche Inc.
The approved product has an estimated market size of US$ 391 million for the12 months ending February 2016 according to IMS.
Vancomycin Hydrochloride for Injection is an antibiotic used in the treatment of severe infections caused by susceptible strains of methicillin-resistant (Beta-lactam resistant) staphylococci and others. The approved product has an estimated market size of US$ 94 million for the twelve months ending January 2016 according
to IMS.
The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Vancomycin® Hydrochloride for Injection USP, 500 mg/vial and 1 g/vial, of Fresenius Kabi USA, LLC.
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