Zydus Cadila gets USFDA nod to market injection to cure liver injury

AHMEDABAD | MUMBAI | RAJKOT – Cadila Healthcare Ltd in a regulatory filing submitted to the Exchanges in India said of having got US FDA (Food & Drug Administration) nod to market an injection to cure liver injury.

Zydus Cadila has received the final approval from the USFDA to market Acetylcysteine Injection (US RLD – Acetadote Injection), 6g/30 mL (200 mg/mL).

It is an antidote for acetaminophen overdose indicated to prevent or lessen hepatic injury after ingestion of a potentially hepatotoxic quantity of acetaminophen.

It will be manufactured at the group’s formulations manufacturing facility at Moraiya, Ahmedabad.


ANDA SCORE

In line with this, the group now has 211 approvals and has so far filed over 330 ANDAs (Abbreviated New Drug Applications) since the commencement of the filing process in FY 2003-04.

Zydus Cadila is an innovative, global pharmaceutical company that discovers, develops, manufactures and markets a broad range of healthcare therapies.

The group employs nearly 23,000 people worldwide and is dedicated to creating healthier communities globally.

Zydus aspires to be a research-based pharmaceutical company by 2020.


Announcement of one more approval from USFDA hit the exchanges on Saturday when the bourses in India have shut for the weekend, it will be interesting to see how investors & traders react to the announcement, when Bourses in India open for trading session on Monday.


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