Drug Approval | January 17, 2022
Glenmark Pharmaceuticals receives ANDA tentative approval for Regadenoson injection
The company has 47 ANDA's pending approval with the U.S.FDA
The company has 47 ANDA's pending approval with the U.S.FDA
The group now has 325 approvals and has so far filed over 400 ANDAs since the commencement of the filing process in FY 2003-04.
Gland Pharma believes that they are amongst one of the first to file for this product and may be eligible for 180 days of generic drug exclusivity
The group now has 324 approvals and has so far filed over 400 ANDAs
This product will be manufactured at Lupin’s Pithampur facility In India
Zydus’ Sitagliptin base contains the active moiety Sitagliptin in a different form than used in the branded reference product, Januvia (Sitagliptin Phosphate)
Lenalidomide is used to treat cancer and also some anaemia disorders
Sitagliptin tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
Pemetrexed is used to treat certain types of cancers such as lung cancer, mesothelioma. It is a chemotherapy drug that works by slowing or stopping the growth of cancer cells
According to IQVIA sales data for the 12 month period ending April 2021, the Ofev Capsules, 100 mg and 150 mg market achieved annual sales of approximately US $1.6 billion
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