Drug Approval | August 27, 2021
Aurobindo subsidiary, Eugia gets US FDA approval for Cyclophosphamide injection
The product will be available in 500 mg/2.5 mL and 1 g/5 mL vials
The product will be available in 500 mg/2.5 mL and 1 g/5 mL vials
First and only therapy approved by the FDA for the treatment of pruritus associated with chronic kidney disease (CKD-aP) in adults undergoing hemodialysis
XELJANZ is the first and only Janus kinase (JAK) inhibitor approved in Europe for the treatment of polyarticular JIA and juvenile PsA and has received regulatory approval in four indications in the European Union, the most of any JAK inhibitor
Zydus was the first to file an ANDA for Tofacitinib extended-release tablets 22 mg and currently holds 180-day exclusivity on this strength
The vaccine will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of Covid-19 disease
It is the only biopharmaceutical company in India to offer all three dosage strengths of the drug (125mcg, 250mcg, and 500mcg)
FDA approval of the first interchangeable biosimilar insulin will drive the US Insulin biosimilar market, says Kuick Research.
Cosentyx is a proven treatment, supported by long-term five-year sustained efficacy and safety data across several inflammatory conditions and with more than 500,000 patients treated worldwide since launch
Brivaracetam tablets are indicated for the treatment of partial-onset seizures in patients four years of age and older
Lenalidomide is used to treat cancer and also some anaemia disorders
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