Zydus receives tentative approval from USFDA for Tofacitinib tablets
New Delhi: Drug firm Zydus Cadila Saturday said it has received tentative approval from the US health regulator to market Tofacitinib tablets, used for the treatment of rheumatoid arthritis.
Tofacitinib is used alone or with other medications to treat moderate to severe forms of rheumatoid arthritis, the company said in a BSE filing.
It helps to decrease pain, tenderness and swelling in the joints, it added.
It will be manufactured at the group's formulations manufacturing facility at Moraiya, Ahmedabad.
The group now has 260 approvals and has so far filed over 350 abbreviated new drug applications (ANDAs) since the commencement of the filing process in FY 2003-04, it added.