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Zydus receives final approval from the USFDA for Acetazolamide ER Capsules


Zydus receives final approval from the USFDA for Acetazolamide ER Capsules

Acetazolamide is a potent carbonic anhydrase inhibitor. Acetazolamide ER capsules are used to treat certain types of glaucoma (caused by increased ocular pressure) and to treat or prevent altitude sickness (acute mountain sickness).

Ahmedabad: Zydus Cadila has received the final approval from the USFDA to market Acetazolamide ER Capsules (US RLD – Diamox) used to treat certain types of glaucoma. It will be manufactured at the group’s formulations manufacturing facility at Moraiya, Ahmedabad.

Also Read: Zydus receives final approvals from USFDA for Betamethasone Dipropionate, Amlodipine and Atorvastatin tablets

Acetazolamide is a potent carbonic anhydrase inhibitor. Acetazolamide ER capsules are used to treat certain types of glaucoma (caused by increased ocular pressure) and to treat or prevent altitude sickness (acute mountain sickness).

The group now has 246 approvals and has so far filed over 330 ANDAs since the commencement of the filing process in FY 2003-04.

An abbreviated new drug application (ANDA) contains data which is submitted to FDA for the review and potential approval of a generic drug product, according to the FDA website.

Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, lower cost alternative to the brand-name drug it references.

Zydus Cadila is a global pharmaceutical company that discovers, develops, manufactures and markets a broad range of healthcare therapies. The group employs over 23,000 people worldwide.

“Zydus aspires to be a research-based pharmaceutical company by 2020,” the company said in a regulatory filing.

Also Read: Zydus Cadila gets USFDA nod for Aripiprazole tablets



Source: self
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