Pharmacy Bulletin 07-02-21

Pharmacy Bulletin 07-02-21

We share important prescription drug information to help you stay informed about updates concerning particular prescription medicines.

VativoRx Bottle update

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 Genentech’s 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 Specialty’s Perforomist (formoterol fumarate) inhalation solution. June 22, 2021

Toviaz® (fesoterodine fumarate) – New indication

The FDA approved Pfizer’s 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