Drug Approval | April 18, 2022
SonoScape receives USFDA 510(k) clearance for HD-550 Endoscopy system
The HD-550 endoscopy system has been available outside of the USA since 2019
The HD-550 endoscopy system has been available outside of the USA since 2019
This product will be manufactured at Lupin’s Nagpur facility in India
The drug will be manufactured at the group's injectables manufacturing facility at Jarod, Gujarat
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 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
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