Zydus Cadila has received the tentative approval from the USFDA to market Mirabegron Extended-Release Tablets (US RLD- Myrbetriq® Extended-Release Tablets), 25 mg and 50 mg. Mirabegron is selective beta 3-adrenoceptor agonist approved for the treatment of Overactive Bladder (OAB), a chronic condition of the lower urinary tract characterised by symptoms of urinary urgency, with or without urge incontinence. It will be manufactured at the group’s manufacturing facility at SEZ, Ahmedabad. The group now has 259 approvals and has so far filed over 350 ANDAs since the commencement of the filing process in FY 2003-04.
Zydus receives tentative approval from the USFDA for Tofacitinib Tablets
Zydus Cadila has received the tentative approval from the USFDA to market Tofacitinib Tablets (US RLD – Xeljanz® Tablets), 5 mg. Tofacitinib is used alone or with other medications (such as methotrexate) to treat moderate to severe forms of rheumatoid arthritis. It helps to decrease pain, tenderness and swelling in the joints. 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 ANDAs since the commencement of the filing process in FY 2003-04.