US FDA Approves Zydus Lifesciences’ Tavaborole Topical Solution


Zydus Lifesciences Ltd., a Canadian pharmaceutical manufacturer, announced on Friday that the United States Food and Drug Administration (USFDA) has granted final approval for the production and distribution of Tavaborole Topical Solution 5%.

According to the company’s exchange filing, Tavaborole topical solution is indicated for the treatment of fungal toenail infections, infections that can cause nail discoloration, splitting, or pain. According to the official release, the medication will be manufactured at the group’s topical manufacturing facility in Ahmedabad, India, Changodar.

5 percent of Tavaborole Topical Solution’s annual sales in the United States were $3.1 million, according to the pharmaceutical giant. The gathering presently has 361 endorsements and has so far documented more than 440 (as of December 31, 2022) ANDAs starting from the beginning of the recording system in FY 2003-04.

Recently, Zydus Lifesciences got last endorsement from USFDA to fabricate and advertise Azithromycin tablets. For the third quarter that ended on December 31, 2022, the company reported a 24.48 percent increase in consolidated net profit, which stood at Rs 622.9 crore. During the same time frame in the previous fiscal year, the company had earned Rs 500.4 crore in consolidated net profit.

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Compared to the same time last year, the consolidated total revenue from operations for the current quarter was Rs 4,362.3 crore. When compared to the same time last year, when expenses totaled Rs 3,096.3 crore, the third quarter’s total was higher at Rs 3,620.7 crore.