USFDA grants approval to Zydus Cadila for Tofacitinib extended-release tablets

Zydus Cadila today announced that it has received tentative approval from USFDA to market Tofacitinib extended-release tablets, 11 mg (US RLD: Xeljanz XR® tablets).

The tablet is recommended for the treatment of adult patients with moderately to severely active ulcerative colitis (UC), a condition in which, there are inflammation and ulcers of the colon & rectum.

According to a report by Reports and Data, the global ulcerative colitis drug market is forecasted to reach approximately USD 10.25 billion by the year 2027. As per Pfizer, about 1 million people are affected by UC each year. The growth rate witnessed in the disease is resultant of changing lifestyle that triggers the number of patients affected by this condition. The key participants in this segment include AbbVie Inc., Bausch Health Companies Inc., Johnson & Johnson, Novartis AG, Boehringer Ingelheim GmbH, Merck & Co., Teva Pharmaceuticals Ltd., Takeda Pharmaceuticals, Shire, Pfizer Inc.

Zydus Cadila group’s formulation manufacturing facility at SEZ, Ahmedabad will manufacture the drug.

Cadila Healthcare limited stock closed at 422.50, 1.87 per cent lower than the previous day. The intraday high was 437 and the intraday low was 419.70.