Pii to Manufacture FDA-approved Bretylium Tosylate Injection Drug Product
HUNT VALLEY, Md., Jan. 9, 2019 /PRNewswire/ -- Pharmaceutics International, Inc. (Pii), a Contract Development and Manufacturing Organization (CDMO) headquartered in Hunt Valley, Maryland, is pleased to announce its partner, Academic Pharmaceuticals, Inc., received FDA approval of Bretylium Tosylate Injection USP, 500 mg/10 mL (50 mg/mL) Single-Dose Vials on December 21, 2018. Bretylium Tosylate Injection is indicated for the prophylaxis and therapy of ventricular fibrillation; treatment of life-threatening ventricular arrhythmia that has failed to respond to first-line antiarrhythmic agents. Pii 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 U.S.
"We are pleased to gain approval of this additional therapy to treat ventricular fibrillation offering health care providers alternative options to treat this life-threatening condition. Bretylium Tosylate Injection USP, 500 mg/10 mL is the 11th FDA product approval and 3rd injectable product approval, for Pii and its partners, during the past two years. This most recent approval follows the tentative approval of the first syringe product filed from Pii, thus expanding Pii's injectable product offering to include terminally sterilized vials, aseptically filled vials, and syringe products," said Dr. Syed Abidi, Pii's Chairman and CEO. "Bretylium Tosylate is a uniquely effective agent for the treatment of ventricular tachycardia and ventricular fibrillation in a cardiac arrest. It is the only drug that can pharmacologically convert ventricular fibrillation, it is an alternative to Amiodarone and more effective than Lidocaine," added Dr. John Somberg, President of Academic Pharmaceuticals, Inc.
About Pharmaceutics International, Inc.
Pii is a privately held CDMO providing dosage form development and cGMP manufacturing services to the global pharmaceutical industry. Headquartered in Hunt Valley, Maryland USA, Pii's services include pre-formulation development, and clinical and commercial cGMP manufacturing of parenterals, liquid solutions and oral solids, including soft gels, tablets and capsules. In addition, the Company offers containment suites to handle potent drugs and Schedules I-V controlled substances. For more information, please visit www.pharm-int.com.
Contact:
Syed E. Abidi, Ph.D., Chairman and CEO
Pharmaceutics International, Inc.
10819 Gilroy Road
Hunt Valley, MD 21031
Phone: (410) 584-0001
Email: [email protected]
SOURCE Pharmaceutics International, Inc.
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