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.
OrderPoint was designed as an advanced DTR solution from its first release in 2016.
The decision follows authorization from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) in May 2022.
GlobalData’s ‘Pharmaceutical Intelligence Center’ observes that India is still in the nascent stage of developing these potential therapies as currently only four cell/gene therapy molecules are being developed in the country.
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
First PARP inhibitor to demonstrate clinical benefit in radiographic progression-free survival in combination with a new hormonal agent with or without homologous recombination repair gene mutations
The estimated capex is to the tune of Rs. 140 crore to be funded through debt and internal accrual
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.
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