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The US health regulator has provided its final approval to Aurobindo Pharma for manufacturing and marketing anti-viral Valganciclovir tablets in the American market.
Aurobindo Pharma has said in a BSE filing that “The company has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market Valganciclovir Tablets USP, 450 mg.”
According to the firm, the product is expected to be launched in the first quarter of the current fiscal.
It further said that the approved ANDA (Abbreviated New Drug Applications) is bioequivalent and therapeutically equivalent to the reference listed drug product Valcyte of Hoffman-La Roche Inc.
