Drug Approval | August 19, 2022
Lupin receives approval from U.S. FDA for Rufinamide Tablets USP
The product will be manufactured at Lupin's facility in Goa, India.
The product will be manufactured at Lupin's facility in Goa, India.
The decision is based on the outcome of a prespecified interim analysis of the Phase 3 AMEERA-5 trial
The study concluded that elevated levels of two proteins help predict how a person will recover from a traumatic brain injury (TBI), providing important information to determine appropriate care
Meclizine Hydrochloride Tablets had estimated annual sales of USD 29 million in the U.S.
The approved product has an estimated market size of around US$ 606 million for the twelve months ending June 2022, according to IQVIA.
ELCYS is the only FDA-approved cysteine hydrochloride injection on the market for use as an additive to amino acid solutions
QIAstat-Dx Viral Vesicular Panel tests for six pathogens that produce similar symptoms
All claims made by Seagen regarding Daiichi Sankyo antibody drug conjugates are denied
The product will be manufactured at Lupin’s facility in Goa, India.
Use of IVUS recommended in all phases of lower extremity arterial and venous revascularization procedures to guide clinical decisions
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