New Delhi, India: Zydus Cadila, a pharmaceutical company, said on Monday that it has obtained final clearance from the US Food and Drug Administration to commercialise Tofacitinib extended-release tablets, which are used to treat rheumatoid arthritis. The medication has been approved by the US Food and Drug Administration (USFDA) in 11 mg and 22 mg doses, according to the firm.
According to Zydus, the firm was the first to file an abbreviated new drug application (ANDA) for Tofacitinib extended-release tablets 22 mg and so has 180-day exclusivity on this strength.
New Delhi, India: Zydus Cadila, a pharmaceutical company, said on Monday that it has obtained final clearance from the US Food and Drug Administration to commercialise Tofacitinib extended-release tablets, which are used to treat rheumatoid arthritis. The medication has been approved by the US Food and Drug Administration (USFDA) in 11 mg and 22 mg doses, according to the firm.
According to Zydus, the firm was the first to file an abbreviated new drug application (ANDA) for Tofacitinib extended-release tablets 22 mg and so has 180-day exclusivity on this strength.
