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Pharmacy Bulletin 06-11-21

Pharmacy Bulletin 06-11-21

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

VativoRx Bottle update

Brexafemme® (ibrexafungerp) – New drug approval

SCYNEXIS announced the FDA approval of Brexafemme (ibrexafungerp), for the treatment of adult and post-menarchal pediatric females with vulvovaginal candidiasis (VVC). June 2, 2021

Camcevi® (leuprolide) – New drug approval

Foresee Pharmaceuticals announced the FDA approval of Camcevi (leuprolide), for the treatment of adult patients with advanced prostate cancer. May 26, 2021

Noxafil® PowderMix, Noxafil® (posaconazole) – New formulation approval, expanded indication

The FDA approved Merck’s Noxafil PowderMix delayed-release oral suspension, for the prophylaxis of invasive Aspergillus and Candida infections in pediatric patients 2 years of age and older (who weigh 40 kg or less) who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy. May 31, 2021

Ryplazim® (plasminogen, human-tvmh) – New orphan drug approval

The FDA announced the approval of Liminal BioSciences’ Ryplazim (plasminogen, human-tvmh), for the treatment of patients with plasminogen deficiency type 1 (hypoplasminogenemia). June 4, 2021

Wegovy™ (semaglutide) – New drug approval

The FDA announced the approval of Novo Nordisk’s Wegovy (semaglutide), as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of 30 kg/m2 or greater (obesity) or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (eg, hypertension, type 2 diabetes mellitus [T2DM], or dyslipidemia). June 4, 2021

Bepreve® (bepotastine) – First-time generic

Mylan launched an AT-rated generic version of Bausch Health’s Bepreve (bepotastine) ophthalmic solution. June 1, 2021

Ultomiris® (ravulizumab-cwvz) – Expanded indication

Alexion announced the FDA approval of Ultomiris (ravulizumab-cwvz), for the treatment of adult and pediatric patients one month of age and older with paroxysmal nocturnal hemoglobinuria (PNH). June 7, 2021