Zydus gets USFDA final approval for Acetazolamide tablets

Zydus Lifesciences Ltd on Thursday said it has received final approval from the US health regulator to manufacture and market its generic Acetazolamide tablets used in the treatment of glaucoma.

The approval by the US Food and Drug Administration (USFDA) is for Acetazolamide tablets of strengths 125 mg and 250 mg, Zydus Lifesciences said in a regulatory filing.

The product will be manufactured at the group's formulation manufacturing facility in Baddi, Himachal Pradesh, it added.

Acetazolamide is used to treat glaucoma, a condition in which increased pressure in the eye can lead to gradual loss of vision. It decreases the pressure in the eye, the company said.

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It further said acetazolamide is also used to reduce the severity and duration of symptoms such as upset stomach, headache, shortness of breath, dizziness, drowsiness, and fatigue, of altitude sickness.

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

Acetazolamide tablets 125 mg and 250 mg had annual sales of USD 16 million in the US, the company said citing IQVIA MAT December 2022 data.

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