Drug Approval | February 03, 2022
Granules receives ANDA approval for anti-depressant medication
It has a total of 50 ANDA approvals from USFDA
It has a total of 50 ANDA approvals from USFDA
Pegfilgrastim is indicated to reduce the duration of neutropenia and the incidence of febrile neutropenia in patients receiving chemotherapy
It would be the first protein-based alternative available in Israel
Potassium chloride is used to prevent or to treat low blood levels of potassium
Glenmark’s current portfolio consists of 173 products authorized for distribution in the U.S. marketplace and 46 ANDA’s pending approval with the U.S. FDA
According to IQVIA sales data for the 12-month period ending November 2021, the Ziac tablets, 2.5 mg/6.25 mg, 5 mg/6.25 mg, and 10 mg/6.25 mg market achieved annual sales of approximately US $ 30.3 million
The FDA grants ODD status to medicines and potential new medicines intended for the treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the US
Pfizer is evaluating the FDA’s comments and will work with the agency to determine an appropriate path forward
Phase 1/2 trial of E-602 expected to open in Q1 2022 in patients with solid tumours
Quviviq is a dual orexin receptor antagonist, which blocks the binding of the wake-promoting neuropeptides orexins and is thought to turn down overactive wakefulness, as opposed to treatments that generally sedate the brain
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