Zydus Cadila gets US FDA nod to market anti-arthritis drug

AHMEDABAD | MUMBAI | RAJKOT – In a regulatory filing submitted to the Indian Bourses on Thursday, Ahmedabad headquartered and Dr Pankaj Patel led Cadila Healthcare Ltd (Zydus Cadila Group) said of having received regulatory approvals from US FDA (Food & Drugs Department) to market anti-arthritis drug.

Zydus Cadila has received the tentative approval from the USFDA to market Colchicine Tablets USP (US RLD — ColcyrsTM), 0.6 mg, the press release said.

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

This medication is used to prevent or treat attacks of gout (also called gouty arthritis).

This condition is caused by high uric acid levels in the blood.

An attack of gout occurs when uric acid causes inflammation (pain, redness, swelling, and heat) in a joint.

This medication is also used to prevent attacks of pain in the abdomen, chest or joints caused by a genetic autoinflammatory
disease (called as familial Mediterranean fever).

The group now has 223 approvals and has so far filed over 330 ANDAs since the commencement of the filing process in FY 2003-04.

Announcement had hit the exchanges in India on Thursday, but the Indian Bourses observed trading holiday on Thursday, to celebrate the festival of Dushera in India.