Drug Approval | April 15, 2022
Lupin receives approval from USFDA for Desvenlafaxine extended-release tablets 25 mg
The product will be manufactured at Lupin’s facility in Goa, India
The product will be manufactured at Lupin’s facility in Goa, India
An RMAT confers eligibility for accelerated approval and priority review of biologics licensing applications (BLA)
Lidocaine and Prilocaine Cream USP, 2.5%/2.5% has an estimated market size of US $ 29 million for twelve months ending Dec. 2021 according to IQVIA
The MoU sets down the guidelines for the establishment of an integrative medicine unit, joint research and academic activities in various fields of interest in Ayurveda and modern medicine
The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Pradaxa Capsules of Boehringer lngelheim
Aveir VR is specifically designed to be retrieved when therapy needs to evolve or the device needs to be replaced
If approved, it will be the first USFDA-approved immunomodulator for the treatment of Covid-19 in hospitalised patients
It also secures US $ 10 million for US launch and commercialization
Yescarta is First CAR T-cell therapy to receive NCCN treatment guideline category 1 recommendation --
No new studies have been requested
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