Drug Approval | 16 August 2023
Eugia Pharma receives USFDA Approval for Icatibant Injection
This is the 166th ANDA out of Eugia Pharma Speciality Group facilities
This is the 166th ANDA out of Eugia Pharma Speciality Group facilities
The inspection was conducted at its Goa, Vema manufacturing facility
Fluocinolone Acetonide Oil (RLD Derma-Smoothe/FS®) had estimated annual sales of USD 10 million in the U.S. (IQVIA MAT June 2023)
The inspection closed with zero observations and a classification of No Action Indicated
The product is being launched in August 2023
Merck continues progress in helping to protect people at risk of Zaire ebolavirus disease
The inspection was conducted at Granules Pharmaceuticals Inc. (GPI) from July 31, 2023 to August 03, 2023
Zydus' Indomethacin suppositories also been granted 180-day CGT exclusivity to market this product.
Norgestrel and Ethinyl Estradiol Tablets USP (RLD Lo/Ovral-28) had an estimated annual sale of USD 34 million in the U.S. (IQVIA MAT Mar 2023)
Jemperli is the only immuno-oncology treatment approved in the frontline setting for this patient population in combination with chemotherapy
The approved product has an estimated market size of around US$ 210 million for the twelve months ending May 2023
Tiotropium (as bromide monohydrate) 18 micrograms powder for inhalation in capsule
Erdafitinib is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma
The approval allows treatment of heart failure patients irrespective of the ejection fraction based on new trial DELIVER conducted by AstraZeneca
The agency issued a Form 483 with 6 observations for Drug Substance, Drug Product units and Quality Control laboratories
Aurobindo will respond to the US FDA within the stipulated timelines
This product would be manufactured at Lupin's Nagpur facility in India
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