Drug Approval | December 26, 2024
Aarti Drugs receives EIR from USFDA for Tarapur API facility
This facility is considered to be in a minimally acceptable state of compliance with regard to current GMP
This facility is considered to be in a minimally acceptable state of compliance with regard to current GMP
The technical program will run in four sessions and a panel discussion on “Challenges in translation of medical technologies”
Divalproex Sodium Delayed-Release Capsules USP, 125 mg have an estimated market size of US$ 61.1 million for twelve months ending September 2024 according to IQVIA
FDC Ltd has received final approval from USFDA for the company's Abbreviated New Drug Application (ANDA) for Cefixime 400 mg Tablets
Bevqolva 25 mg/mL concentrate for infusion will be available in 4 mL (100 mg) and 16 mL (400 mg) single-use vials for infusion into veins
New capsule manufacturing lines added at Lonza Capsules & Health Ingredients (CHI) facilities in Rewari and Suzhou
Accelerated approval is based on 61% overall response rate compared to 40% in control arm in the
Lidocaine and Prilocaine cream had annual sales of US $22.05 million in the United States (IQVIA MAT October 2024)
The report also revealed that 87% of physicians agreed that FEE recommendations would help to improve the speed of recovery
In the US, the compassionate use approvals are provided by FDA in the form of individual patient-specific expanded-access IND
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