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
The company will manufacture the products at its US FDA approved oral dosage facility at Goa in India
Zydus was the first to file an ANDA for Tofacitinib extended-release tablets 22 mg and currently holds 180-day exclusivity on this strength
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
New treatment options are critical, as approximately half of all people with heart failure die within five years of diagnosis. Heart failure accounts for more than one million hospitalisations a year in the US
Results from year two of the pivotal Phase 3 KITE clinical trial reaffirmed visual acuity gains and fluid reduction findings as well as safety profile from year one
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
This therapy may provide the first potential oral treatment for COVID-19, recognizing the global emergency of new SARS-CoV-2 variants
It is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
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