Astepro® Allergy and Children’s Astepro Allergy (azelastine) – New partial over-the-counter approval
The FDA announced the approval of partial over-the-counter (OTC) use of Bayers Astepro Allergy and Children’s Astepro Allergy (azelastine) 0.15%, for the temporary relief of nasal congestion, runny nose, sneezing and itchy nose due to hay fever or other upper respiratory allergies in adults and children 6 years of age and older. June 17, 2021
Pradaxa® (dabigatran etexilate) – New formulation approval, new indication
The FDA announced the approval of Boehringer Ingelheims Pradaxa (dabigatran) oral pellets, for the treatment of venous thromboembolic events (VTE) in pediatric patients aged 3 months to less than 12 years of age who have been treated with a parenteral anticoagulant for at least 5 days and to reduce the risk of recurrence of VTE in pediatric patients aged 3 months to less than 12 years of age who have been previously treated. June 22, 2021
Soaanz® (torsemide) – New drug approval
The FDA approved Sarfez Pharmaceuticals Soaanz (torsemide), in adults for the treatment of edema associated with heart failure or renal disease. June 14, 2021
StrataGraft® (allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen-dsat) – New orphan drug approval
The FDA announced the approval of Mallinckrodts StrataGraft (allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen-dsat), for the treatment of adults with thermal burns containing intact dermal elements for which surgical intervention is clinically indicated (deep partial-thickness burns). June 15, 2021
Intelence® (etravirine) – First-time generic
Amneal launched an AB-rated generic version of Jansse’s Intelence (etravirine) tablets. June 15, 2021
Ayvakit (avapritinib) – New indication
Blueprint Medicines announced the FDA approval of Ayvakit (avapritinib), for the treatment of adult patients with advanced systemic mastocytosis (AdvSM). AdvSM includes patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated hematological neoplasm (SM-AHN), and mast cell leukemia (MCL). June 16, 2021