New Delhi : Aurobindo Pharma has received final approval from the US health regulator to manufacture and market anti-viral Valganciclovir tablets in the American market.
“The company has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market Valganciclovir Tablets USP, 450 mg,” Aurobindo Pharma said in a BSE filing.
The firm said this product is expected to be launched in the first quarter of the current fiscal.
The approved ANDA (Abbreviated New Drug Applications) is bioequivalent and therapeutically equivalent to the reference listed drug product Valcyte of Hoffman-La Roche Inc, it added.
According to IMS, the approved product has an estimated market size of USD 391 million for the twelve months ending February 2016, Aurobindo Pharma said.
Valganciclovir tablet 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.
Aurobindo Pharma said it has also received final approval from the USFDA to manufacture and market antibiotic Vancomycin Hydrochloride for injection, used for the treatment of severe infections, in the American market.
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 pharma company has a total of 251 ANDA approvals (215 final approvals including 10 from Aurolife Pharma LLC and 36 tentative approvals) from the US.