Express Pharma

Zydus Cadila gets US FDA nod for glaucoma drug

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The capsules will be manufactured at the group’s formulations manufacturing facility at Moraiya, Ahmedabad

Zydus Cadila has received the final approval from the US FDA to market Acetazolamide ER capsules that are used to treat certain types of glaucoma. The capsules will be manufactured at the group’s formulations manufacturing facility at Moraiya, Ahmedabad, the company said in a regulatory filing. 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 2003-04,” it said.

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 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 filing added.

 

 

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