Zydus Cadila gets USFDA nod for Tofacitinib ER tablets
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Ahmedabad: Drugmaker, Zydus Cadila, today announced that the company has received final approval from the United States Food & Drug Administration (USFDA) to market Tofacitinib extended-release tablets, 11 mg and 22 mg in the United States (ANDA-214264 and US RLD: XELJANZ XR).
Zydus was the first abbreviated new drug application (ANDA) filer on Tofacitinib extended-release tablets 22 mg and currently holds 180-day exclusivity on this strength, the company said in a release.
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