US FDA Approved Zydus Lifesciences’ Cold Sore Healing Cream


Zydus Lifesciences’ Acyclovir Cream, 5%, which is used to treat cold sores on the face and lips, received final approval from the United States Food and Drug Administration (FDA). Blisters known as cold sores are brought on by the herpes simplex virus.

Acyclovir is a member of the antiviral class of drugs. The product will soon be available for purchase in the US market. The group’s topical manufacturing facility in Changodar, Ahmedabad, India, is where the drug will be made.

Acyclovir cream 5 percent had annual sales of $16.9 million in the United States for the twelve months ending in December 2022, according to IQVIA data.

Zydus Lifesciences now has 348 approvals from the US Food and Drug Administration. Over 440 ANDAs have been submitted by the pharma giant thus far.

The company received approval from the US drug regulator in February, 2023 for Sirolimus tablets, which are used to prevent kidney transplant rejection.

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The company released its earnings for the December quarter this past month. When compared to the same quarter last year, its profit increased by 11.7% to Rs 547.9 crore, compared to Rs 490.6 crore. Additionally, its EBITDA margin increased to 21.9 percent from 20.6% in the previous quarter.