Drug Approval | August 03, 2022
USFDA issues 3 observations for Aurobindo Pharma’s Unit XI
The company has responded to the warning letter and carried out the committed corrections.
The company has responded to the warning letter and carried out the committed corrections.
The audit is part of the agency's inspection for three product applications filed and slated to be manufactured at this site.
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.
Bisoprolol Fumarate Tablets are used to treat high blood pressure.
Sun Pharma will receive from Cassiopea the exclusive right to develop and commercialize WINLEVI in Japan, Australia, New Zealand, Brazil, Mexico and Russia.
Abbott has recently received the US Food and Drug Administration nod to use its DBS device for treatment-resistant depression
Allegra-D had U.S. retail sales of approximately $45 million as of May 2022 according to IRI.
The Elecsys Amyloid Plasma Panel has the potential to ensure better identification of patients that require further confirmatory testing, supporting a more timely and accessible diagnosis.
Jublia (Efinaconazole) topical solution, 10% had annual sales of $292 million in the United States according to IQVIA data (IQVIA MAT May 2022).
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