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