The United States Food and Drug Administration (USFDA) has granted Zydus Lifesciences final approval to manufacture and market Acetazolamide Tablets USP, 125 mg and 250 mg (USRLD: Diamox Tablets, 125 mg and 250 mg). Acetazolamide is used to treat glaucoma, a condition in which increased eye pressure causes progressive vision loss. Acetazolamide lowers intraocular pressure. Acetazolamide is also used to reduce the severity and duration of altitude sickness symptoms (upset stomach, headache, shortness of breath, dizziness, drowsiness, and fatigue). The medication is used in conjunction with other medications to treat edoema (excess fluid retention) and to help control seizures in certain types of epilepsy.
The product will be manufactured in Baddi, Himachal Pradesh, at the group’s formulation manufacturing facility (India). In the United States, sales of Acetazolamide Tablets USP, 125 mg and 250 mg totaled $16 million (IQVIA MAT Dec. 2022). Since the beginning of the filing process in FY 2003-04, the group has received 358 approvals and has filed over 440 ANDAs.