The shuttering of Teva’s long troubled manufacturing facility in Irvine, California, may create shortages of up to 24 generic sterile injectable drugs, including five essential medications of which the company supplied more than 15% of the market last year, according to an industry group.
Enforcement Report - Week of April 20, 2022
Teva Pharmaceutical is pulling one lot of its injectable leukemia med IDArubicin hydrochloride in the U.S. after an internal inspection uncovered silica and iron oxide particulate matter in a lone drug vial, the company said in a recall notice published on the FDA’s website. The defect hasn’t turned up in any other vials, Teva added.
Teva Issues Voluntary Nationwide Recall of One Lot of IDArubicin Hydrochloride Inj
A Phase III clinical trial has found that the combination of all-trans retinoic acid and arsenic trioxide is highly effective in children with standard- and high-risk acute promyelocytic leukaemia (APL).
Enforcement Report - Week of August 25, 2021
Decitabine Plus Chemo Denotes New Induction Therapy Option for AML