Zydus Lifesciences Ltd. (Zydus) on Thursday announced that it has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market Acetazolamide Tablets USP 125 mg and 250 mg.
Acetazolamide Tablets are used in the treatment of glaucoma and in controlling seizures. They also help in easing symptoms of altitude sickness.
The product will be manufactured at Zydus Group’s formulation manufacturing facility in Baddi, Himachal Pradesh.
Acetazolamide is used to treat glaucoma, a condition in which increased pressure in the eye can lead to gradual loss of vision.
The tablets are also used to reduce the severity and duration of symptoms such as upset stomach, headache, shortness of breath, dizziness, drowsiness, and fatigue caused by altitude sickness.
The drug is used with other medicines to reduce edema (excess fluid retention) and to help control seizures in certain types of epilepsy.
According to IQVIA data, Acetazolamide Tablets USP 125 mg and 250 mg had annual sales of $16 million in the United States in 2022.
With the latest nod from the USFDA, Zydus Group now has 358 approvals and has so far filed over 440 ANDAs since the commencement of the filing process in the fiscal year 2003-04.
Zydus last month received USFDA approval for Doxepin Hydrochloride capsules USP 150 mg used to treat depression and anxiety. It also received regulatory final approval for Erythromycin Tablets USP 250 mg and 500 mg which are used to treat a wide variety of bacterial infections last month.
The company also came under the USFDA glare as it received three observations during the pre-approval inspection (PAI) and GMP audit of Pharmez, Ahmedabad manufacturing facility SEZ-1 by the USFDA.
The inspection was conducted between March 20 and March 24, 2023.
Shares of Zydus Lifesciences are trading 0.62 percent higher at Rs 496.15. The stock high a fresh 52-week high of Rs 498 earlier in the session on Thursday.
