Tavneos – FDA Approved
The U.S. Food and Drug Administration (FDA) approved Tavneos™ (avacopan – ChemoCentryx) capsules. The first oral form of a complement C5a inhibitor, it is indicated to treat adults who have granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA), the two major types of a group of autoimmune conditions collectively known as anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis. Oct. 7, 2021
Tecartus – New Approvals
The FDA approved a second indication for Tecartus® (brexucabtagene autoleucel) suspension for infusion, which is made by Kite, a Gilead Sciences’ company. It now is indicated to treat adults who have B-cell precursor acute lymphoblastic leukemia (ALL) that has returned despite previous treatment or that has become resistant to prior drug therapy. Oct. 1, 2021
Hand Sanitizers – Recall
Recently, the FDA revised its safety communications for over-the-counter (OTC) hand sanitizers, which should contain 60% or more of ethanol, but no other alcohols. Consumers are being warned not to buy or use any unscented hand sanitizing products distributed by a company called artnaturals. Like multiple other hand sanitizer brands, the artnaturals products were found to contain unacceptable contamination. In this case, acetaldehyde, benzene and other impurities.
COVID-19 Vaccines and Monoclonal Antibodies – An update
As the COVID-19 pandemic continues to evolve, multiple decisions about prevention and treatment options are due to be announced in the next few weeks. October 8, 2021
Teligent Pharma – Recall of lidocaine topical solution
Teligent Pharma announced a voluntary, patient-level recall of five lots of lidocaine topical solution 4% because testing has found it to be super potent based on an out of specification result obtained at the 18-month stability timepoint. October 12, 2021
Lupin – Recall of irbesartan and irbesartan/hydrochlorothiazide (HCTZ)
Lupin announced a consumer level recall of irbesartan and irbesartan/HCTZ tablets because certain active pharmaceutical ingredient (API) batches were above the specification limit for N-nitrosoirbesartan impurity. October 12, 2021