Zydus Cadila gets FDA permission for generic Xeljanz
Tofacitinib extended-release tablets are indicated to treat moderate to severely active rheumatoid arthritis in those whom methotrexate did not work well or cannot be tolerated.
Zydus Cadila has received the Food and Drug Administration’s green light for tofacitinib extended-release tablets, in dosage strengths of 11 mg and 22 mg.
The medication is the generic of Pfizer's Xeljanz. It is used to treat moderate to severely active rheumatoid arthritis in those whom methotrexate did not work well or cannot be tolerated.
Zydus was the first ANDA filer on tofacitinib extended-release tablets 22 mg and currently holds 180-day exclusivity on this strength.
Tofacitinib extended-release tablets had annual sales of approximately $2,082 million for the year ended June 2021, according to IQVIA data.
The drug will be manufactured at the group’s formulation manufacturing facility in SEZ, Ahmedabad.