Drug Approval | 19 August 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 follows authorization from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) in May 2022.
According to industry sales data, Yondelis generated annual sales of $49.7 million for the twelve months ending June 2022 in the US market.
The OAI classification implies that the US FDA may withhold approval of any pending product applications or supplements filed from this facility till the outstanding observations are resolved
First PARP inhibitor to demonstrate clinical benefit in radiographic progression-free survival in combination with a new hormonal agent with or without homologous recombination repair gene mutations
Meclizine Hydrochloride Tablets had estimated annual sales of USD 29 million in the U.S.
The approved product has an estimated market size of around US$ 606 million for the twelve months ending June 2022, according to IQVIA.
Quetiapine Extended-Release Tablets are indicated for the treatment of Schizophrenia, Bipolar disorder and adjunctive treatment of Major Depressive Disorder (MDD)
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
Company creates Younger T Cells for fighting cancer using its NR2F6 technology
Based on DESTINY-Breast04 results which showed Daiichi Sankyo and AstraZeneca’s ENHERTU reduced risk of disease progression or death by 50% and increased overall survival by more than six months versus chemotherapy
Ivermectin Cream is a used for the treatment of inflammatory lesions of rosacea.
First and only PARP inhibitor to improve invasive disease-free survival, the primary endpoint, and overall survival, a key secondary endpoint, in these patients
The company has responded to the warning letter and carried out the committed corrections.
Strides is the first Indian company to get approval for the product.
The audit is part of the agency's inspection for three product applications filed and slated to be manufactured at this site.
The facility is designed with advanced analytical equipment to provide testing services such as In-vitro Permeation testing
The Velcade Brand and generic had U.S. sales of approximately $1.2 billion MAT for the most recent twelve months ending in May 2022
The product will be manufactured at Lupin's facility in Nagpur, India.
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