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.
GSK reports positive Jideytro data supporting potential first-line lung cancer use
Eloxx Pharmaceuticals commences Phase 2b study of exaluren
Meant Health announces expansion of telehealth access for FDA-approved GLP-1 prescriptions
US FDA grants orphan drug designation for Lundbeck's asedebart
Renova Pharmaceuticals launches first three US generic products
FDA grants Priority Review to Genentech's Enspryng for MOGAD
CordenPharma increases aseptic fill-finish capacity
Biophytis expands BIO101 obesity study to assess weight regain
THX Pharma secures European patent for Batten-1 in juvenile Batten disease
Etcamah–CDK4/6 inhibitor combination approved in US for ESR1-mutated HR-positive breast cancer