Drug Approval | January 28, 2023
USFDA provides exception to Glenmark's Baddi facility
The company will engage with the agency to resolve the import alert at the earliest.
The company will engage with the agency to resolve the import alert at the earliest.
It is administered as a single infusion 30 minutes prior to the start of each chemotherapy cycle that helps prevent, both, acute and delayed phases of CINV
Sacu V is priced at Rs. 19 per tablet for a dose of 50 mg (sacubitril 24 mg + valsartan 26 mg)
The divested brands include Onabet, Halovate, Sorvate, Luligee, Demelan, Aceret, Dosetil, Revize, and Powercort, and their sub-brands
This FDC has been launched under the brand name Zita-PioMet, and contains Teneligliptin (20 mg) + Pioglitazone (15 mg) + Metformin (500mg/1000mg) in a sustained release (SR) formulation
According to IQVIA sales data for the 12-month period ending October 2022, the Cardene Capsules, 20 mg and 30 mg market achieved annual sales of approximately US $10.9 million
The acquisition marks JB Pharma’s entry into the ‘Statin’ segment which is the largest group in the cardiac therapy
The company does not believe that the warning letter will have an impact on disruption of supplies or the existing revenues from operations of this facility
Glenmark’s Sodium Phenylbutyrate Tablets USP, 500 mg, will be distributed in the U.S. by Glenmark Pharmaceuticals USA.
According to IQVIA sales data for the 12-month period ending September 2022, the Gilenya Capsules, 0.5 mg market achieved annual sales of approximately US $1.8 billion
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