USFDA nod to Zydus Lifesciences glaucoma drug Acetazolamide

Ahmedabad: Pharma major, Zydus Lifesciences Limited, has announced that the company has received final approval from the United States Food and Drug Administration
(USFDA) 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 pressure in the eye
can lead to gradual loss of vision. Acetazolamide decreases the pressure in the eye.
Acetazolamide is also used to reduce the severity and duration of symptoms (upset stomach,
headache, shortness of breath, dizziness, drowsiness, and fatigue) of altitude (mountain)

The drug is used with other medicines to reduce edema (excess fluid retention) and
to help control seizures in certain types of epilepsy.

The product will be manufactured at the
group’s formulation manufacturing facility in Baddi, Himachal Pradesh (India).

Acetazolamide Tablets USP, 125 mg and 250 mg had annual sales of USD 16 mn in the United
States (IQVIA MAT Dec. 2022).
The group now has 358 approvals and has so far filed over 440* ANDAs since the
commencement of the filing process in FY 2003-04.

Read also: Zydus Lifesciences secures USFDA approval for Doxepin Hydrochloride Capsules USP, 10 mg, 25 mg, 50 mg, 75 mg, 100 mg

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.

Read also: Zydus Lifesciences bags USFDA nod for Levothyroxine Sodium for Injection for myxedema coma treatment

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