Drug Approval | 04 March 2023
Caplin Steriles gets USFDA approval for Rocuronium Bromide Injection
Rocuronium Bromide Injection is a neuromuscular blocking agent
Rocuronium Bromide Injection is a neuromuscular blocking agent
Vigabatrin for Oral Solution USP, 500 mg had annual sales of USD 233.7 mn in the United States
he product will be launched shortly in the US market.
Apixaban Tablets, 2.5 mg and 5 mg had annual sales of USD 18,876 mn in the United States (IQVIA MAT Dec. 2022).
This combination medicine is used to treat high blood pressure (hypertension).
The company expects the GMP approval from Saudi Food and Drug Authority (SFDA) to soon pave the way for marketing authorizations from the largest market in the GCC region
Losartan potassium tablets are indicated for the treatment of hypertension in adults and pediatric patients 6 years of age and older, to lower blood pressure.
The British-Swedish pharma major certainly has a strong competitive edge for BTC treatment in the country
This sBLA submission is supported by clinical, pre-clinical, and manufacturing data demonstrating the safety, tolerability, and immunogenicity of the bivalent vaccine.
Submissions based on favorable MagnetisMM-3 trial results in patients with relapsed or refractory multiple myeloma
Clinical studies are expected to start in Q2 2023.
Designation based on positive data from Phase 2b KEYNOTE-942/mRNA-4157-P201 trial
This action follows the recent acceptance of the Marketing Authorization Application (MAA) for Pfizer’s RSV vaccine candidate by the European Medicines Agency
Astellas stands on the forefront of healthcare change to turn innovative science into value for patients
Cipla has received 8 inspectional observations in Form 483
Canagliflozin and Metformin Hydrochloride Tablets had annual sales of US $49.4 million in the United States
Data build on previously reported results from the primary endpoint of investigator-assessed radiographic progression-free survival
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