Tuesday, November 2, 2021

Zydus Cadila gets USFDA Fast Track Designation for Saroglitazar

Drug firm Zydus Cadila on Wednesday said it has received Fast Track Designation from the US health regulator for its investigational drug candidate Saroglitazar Mg, indicated for the treatment of a liver disease – primary biliary cholangitis (PBC). Fast Track is a process of the USFDA to expedite the review of drugs to treat serious conditions and fill an unmet medical need. A drug that receives Fast Track Designation is eligible for accelerated approval and priority review, if the relevant criteria are met, Zydus Cadila said in a statement.

The United States Food and Drug Administration (USFDA) has granted Fast Track Designation to Saroglitazar Mg for the treatment of patients with PBC, it added.

“The awarding of Fast Track Designation to Saroglitazar, an investigational candidate for the treatment of PBC, is an important recognition by USFDA to address the serious condition and bridge an unmet medical need in the treatment of PBC patients,” Zydus Cadila Chairman Pankaj R Patel said. The company will continue to work closely with the USFDA for clinical development for Saroglitazar Mg for patients with PBC, he added.

PBC is a liver disease, caused due to the progressive destruction of the bile ducts in the liver, which leads to a reduction of bile flow – a condition referred to as cholestasis, the statement said. Shares of Cadila Healthcare, the listed entity of the Zydus Group, were trading at Rs 470.50 per scrip on BSE, up 1.19 per cent from its previous close.

Source link

Latest Articles

Widely used chemical linked to 1,00,000 US deaths per year: Study

NEW YORK: Daily exposure to phthalates, a group of chemicals used in everything from plastic containers to makeup, may lead to approximately 100,000 deaths...

Foods to Reduce Inflammation and Strengthen the Immune System

Did you know that you can greatly reduce inflammation and boost your immune system by simply incorporating more anti-inflammatory foods and beverages into your...

Personal Selling

INTRODUCTION Early sellers and traders were not held in high esteem. The Roman word for salesman meant ‘Cheater’ and...

Building Muscle on a Vegan Diet

There are a lot of  misconceptions surrounding veganism. The notion that those who practice it are lacking in protein and therefore muscles is the...

Electrodes in brain new hope for severe cases of epilepsy

Neurosurgeons at All India Institute of Medical Sciences have devised a new technique for operating on children suffering from a severe form of epilepsy...