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
This biopharmaceutical facility is one most significant private sector investment ever in the Middletown region
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.
According to industry sales data, Yondelis generated annual sales of $49.7 million for the twelve months ending June 2022 in the US market.
The OAI classification implies that the US FDA may withhold approval of any pending product applications or supplements filed from this facility till the outstanding observations are resolved
The card-to-cloud device was launched into the U.S. and many other markets and is designed to work without an embedded communications module.
The approved product has an estimated market size of around US$ 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
Meclizine Hydrochloride Tablets had estimated annual sales of USD 29 million in the U.S.
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