Pfizer – Recall of Chantix® (varenicline) to warehouse level
The FDA announced a voluntary, warehouse-level recall of nine lots of Pfizer’s Chantix (varenicline) tablets because they may contain levels of a nitrosamine impurity, called N-nitroso-varenicline, above FDA’s acceptable intake limit. July 2, 2021
Actemra® (tocilizumab) – Emergency use authorization approval
The FDA announced the emergency use authorization (EUA) approval of Genentechs Actemra (tocilizumab), for the treatment of COVID-19 in hospitalized adults and pediatric patients (2 years of age and older) who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation. June 24, 2021
Verkazia® (cyclosporine) – New orphan drug approval
Santen Pharmaceutical announced the FDA approval of Verkazia (cyclosporine) ophthalmic emulsion 0.1%, for the treatment of vernal keratoconjunctivitis (VKC) in children and adults. June 24, 2021
Perforomist® (formoterol fumarate) – First-time generic
Teva launched an AN-rated generic version of Mylan Specialtys Perforomist (formoterol fumarate) inhalation solution. June 22, 2021
Toviaz® (fesoterodine fumarate) – New indication
The FDA approved Pfizers Toviaz (fesoterodine fumarate), for the treatment of neurogenic detrusor overactivity (NDO) in pediatric patients 6 years of age and older with a body weight greater than 25 kg. June 17, 2021
Grifols – Withdrawal of Gamunex-C® (immune globulin [human])
Grifols Therapeutics announced a voluntary, consumer-level withdrawal of one lot of Gamunex-C (immune globulin [human]) injection due to a higher rate of allergic/hypersensitivity type reactions, a small number of which were considered medically significant. June 25, 2021