cGMP manufacturing services company Pharmaceutics International Inc (Pii) reported on Wednesday the receipt of the US FDA approval for Bretylium Tosylate Injection in USP 500 mg/10 mL (50 mg/mL) Single-Dose Vials for the treatment of ventricular fibrillation.
On 21 December 2018, the US FDA's approval was awarded to the company's partner, Academic Pharmaceuticals Inc.
The company said Bretylium Tosylate Injection is indicated for the prophylaxis and therapy of ventricular fibrillation as well as for the treatment of life-threatening ventricular arrhythmia that has failed to respond to first-line antiarrhythmic agents.
In conjunction, the company is the exclusive manufacturer of Bretylium Tosylate for Academic Pharmaceuticals Inc, who is currently seeking a commercial partner to license and launch the drug product in the US.
Egetis receives US notice of allowance for MCT8 deficiency composition patent
Ipsen withdraws tazverik across all markets following safety concerns in lymphoma trial
Foresee Pharmaceuticals receives positive CHMP opinion for CAMCEVI 21 mg
Great Novel Therapeutics' GNTbm-38 approved by US FDA for Phase I trial
Johnson & Johnson reports US FDA approval of TECVAYLI plus DARZALEX FASPRO for RRMM
Airiver Medical's Airiver Pulmonary DCB receives US FDA Breakthrough Device Designation
Sanaregen receives FDA clearance for retinal degeneration clinical trial
Esperion to acquire Corstasis, expanding cardiovascular portfolio
ReviR Therapeutics doses first participant in First-in-Human Phase 1 clinical trial of RTX-117