Japanese drugmaker Otsuka Pharmaceutical today announces it has received regulatory approval in Japan for a once-daily form in pediatric patients of Busulfex (busulfan) Injection 60mg.
Enforcement Report - Week of December 16, 2020
AVROBIO, Inc. (Nasdaq: AVRO), a leading clinical-stage gene therapy company with a mission to free people from a lifetime of genetic disease, today announced a new development and commercialization agreement with Saladax Biomedical, Inc. (Saladax), a leading diagnostics provider focused on developing blood tests for personalized dosing, to develop and validate a fully automated nanoparticle immunoassay kit designed to simplify and streamline therapeutic drug monitoring (TDM) for patients treated with the conditioning agent busulfan.
Shilpa Medicare`s Generic Busulfan Receives Approval in US
HUNT VALLEY, Md., March 15, 2019 /PRNewswire/ -- Pharmaceutics International, Inc. (Pii), a Contract Development and Manufacturing Organization (CDMO) headquartered in Hunt Valley, Maryland, is pleased to announce the launch of Busulfan Injection, 6mg/mL in 10mL vials, in partnership with Athenex Pharmaceuticals, Sungen Pharma and Chemwerth. Pii is responsible for all commercial production and Athenex will market and distribute the product in the U.S. Busulfan Injection is indicated for use in combination with cyclophosphamide as a conditioning regimen prior to allogeneic hematopoietic progenitor cell transplantation for chronic myelogenous leukemia.
Pharmaceutics International, Inc. (Pii), a CDMO headquartered in Hunt Valley, MD, in partnership with Athenex Pharmaceuticals, Sungen Pharma and Chemwerth, have launched Busulfan Injection, 6mg/mL in 10mL vials. Pii is responsible for all commercial production and Athenex will market and distribute the product in the U.S. Busulfan Injection is indicated for use in combination with cyclophosphamide as a conditioning regimen prior to allogeneic hematopoietic progenitor cell transplantation for chronic myelogenous leukemia.
PRINCETON, N.J., March 13, 2019 (GLOBE NEWSWIRE) -- SunGen Pharma, a privately held specialty pharmaceutical company which develops, contract manufactures, and sells pharmaceutical finished products, today announced the launch of Busulfan Injection, the second product launch through their joint venture Peterson Athenex with Athenex Pharmaceuticals (Nasdaq:ATNX). The ownership of the approved US ANDA was transferred from Sandoz, a Novartis Division, to SunGen and Athenex.
LINCOLNSHIRE, Ill.--(BUSINESS WIRE)--Nexus Pharmaceuticals Inc. announced today the U.S. Food and Drug Administration (FDA) approval of Busulfan Injection, the company's AP-rated therapeutic equivalent for Busulfex® 60 mg/10 mL (6 mg/1 mL).
Nexus Pharms' Generic Busulfan Receives Approval in US
Hospira’s Generic Busulfan Receives Approval In US