USFDA approves Zydus Lifesciences Tavaborole Topical Solution to treat fungal toenail infections
The drug will be manufactured at the group's topical manufacturing facility at Changodar, Ahmedabad, India.
Ahmedabad: Zydus Lifesciences Limited has received final approval from the United States Food and Drug Administration (USFDA) to manufacture and market Tavaborole Topical Solution, 5% (USRLD: Kerydin Topical Solution).
Tavaborole topical solution is indicated to treat fungal toenail infections. These are the infections that may cause nail discoloration, splitting, or pain.
The drug will be manufactured at the group’s topical manufacturing facility at Changodar, Ahmedabad (India).
Tavaborole Topical Solution, 5% had annual sales of USD 3.1 mn in the United States (IQVIA MAT Feb. 2023). The group now has 361 approvals and has so far filed over 440* ANDAs since the commencement of the filing process in FY 2003-04.
Medical Dialogues team had earlier reported that Zydus Lifesciences Limited had received final approval from the USFDA to manufacture and market Azithromycin Tablets USP, 500 mg (USRLD: Zithromax Tablets). Azithromycin is indicated to treat certain bacterial infections such as bronchitis, pneumonia, sexually transmitted diseases (STD), infections of the ears, lungs, sinuses, skin, throat, and reproductive organs.
Read also: Zydus Lifesciences bags USFDA nod for Azithromycin Tablets to treat certain bacterial infections
Zydus Lifesciences Limited (Formerly known as Cadila Healthcare Limited), an Indian Pharmaceutical company is a fully integrated, global healthcare provider. The company was founded in the year 1952 by Mr. Ramanbhai B. Patel (late), a first-generation entrepreneur and a doyen in the field of Indian Pharmaceuticals.
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