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 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
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.
The product will be manufactured at Lupin’s facility in Goa, India.
Xofluza is the first and only single-dose oral medicine for the treatment of influenza to be approved in the US for children as young as five years of age
Ivermectin Cream is a used for the treatment of inflammatory lesions of rosacea.
he US FDA has issued six observations pursuant to the completion of the audit.
The company has responded to the warning letter and carried out the committed corrections.
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