Drug Approval | August 20, 2022
Swissmedic approves Kapruvia with additional regulatory decisions expected in H2 2022
Therapy recently approved in Canada under the brand name KORSUVA
Therapy recently approved in Canada under the brand name KORSUVA
The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Naproxen Sodium Capsules, 220 mg, of Bionpharma
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.
Genentech will be granted an exclusive license to develop and commercialize the degrader worldwide, and will be fully responsible for the development and commercialization costs.
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.
According to industry sales data, Yondelis generated annual sales of $49.7 million for the twelve months ending June 2022 in the US market.
The decision is based on the outcome of a prespecified interim analysis of the Phase 3 AMEERA-5 trial
The OAI classification implies that the US FDA may withhold approval of any pending product applications or supplements filed from this facility till the outstanding observations are resolved
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
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