Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) for generic Acyclovir Cream, 5 per cent which is an equivalent of US Reference Listed Drug Zovirax Cream, the pharma company said on Thursday in a regulatory filing.
Acyclovir belongs to a class of medications known as antivirals. Acyclovir cream is used to treat cold sores (fever blisters; blisters that are caused by a virus called herpes simplex) on the face or lips. The product will be launched shortly in the US market.
The drug will be manufactured at the group’s topical manufacturing facility at Changodar, Ahmedabad (India). Acyclovir Cream, 5 per cent had annual sales of USD 16.9 million in the United States as per IQVIA MAT December 2022. The group now has 348 approvals and has so far filed over 440* ANDAs since the commencement of the filing process in FY 2003-04.
The company's stock was trading 1.37 per cent higher on Saturday at Rs 472.80 per scrip as of 11:42 IST.