Original New Drug Application Approvals by US FDA (16 - 30 April 2022)

05 May 2022
Original New Drug Application Approvals by US FDA (16 - 30 April 2022)
New drug applications approved by US FDA as of 16-30 April 2022 which includes New Molecular Entities (NMEs) and new biologics. It does not include Tentative Approvals. Supplemental approvals may have occurred since the original approval date.

GLYCOPYRROLATE
  • Active Ingredient(s): Glycopyrrolate
  • Strength: 0.6MG/3ML
  • Dosage Form(s) / Route(s): Injectable; Intravenous, Subcutaneous
  • Company: Fresenius Kabi Usa
  • Approval Date: 21 April 2022
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): indicated:-
    • in anesthesia (adult and pediatric patients)
      • for reduction of airway or gastric secretions, and volume and acidity of gastric secretions, and blockade of cardiac inhibitory reflexes during induction of anesthesia and intubation,
      • intraoperatively to counteract surgically or drug-induced or vagal reflexassociated arrhythmias, and
      • for protection against peripheral muscarinic effects of cholinergic agents.
    • in peptic ulcer (adults)
      • as adjunctive therapy for the treatment of peptic ulcer when rapid anticholinergic effect is desired or oral medication is not tolerated. 
  • Approved Label: 21 April 2022 (PDF)
EPSOLAY
  • Active Ingredient(s): Benzoyl Peroxide
  • Strength: 5%
  • Dosage Form(s) / Route(s): Cream; Topical
  • Company: Sol-gel Technologies
  • Approval Date: 22 April 2022
  • Submission Classification: Not available
  • Indication(s): Not available
  • Approved Label: Not available
VIVJOA
  • Active Ingredient(s): Oteseconazole
  • Strength: 150MG
  • Dosage Form(s) / Route(s): Capsule; Oral
  • Company: Mycovia Pharmaceuticals Inc
  • Approval Date: 26 April 2022
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated to reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in females with a history of RVVC who are NOT of reproductive potential. 
  • Approved Label: 26 April 2022 (PDF)
CAMZYOS
  • Active Ingredient(s): Mavacamten
  • Strength: 2.5MG; 5MG; 10MG; 15MG
  • Dosage Form(s) / Route(s): Capsule; Oral
  • Company: Myokardia Inc
  • Approval Date: 28 April 2022
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of adults with symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (HCM) to improve functional capacity and symptoms.
  • Approved Label: 28 April 2022 (PDF)
CUVRIOR
  • Active Ingredient(s): Trientine Tetrahydrochloride
  • Strength: 300MG
  • Dosage Form(s) / Route(s): Tablet; Oral
  • Company: Orphalan Sa
  • Approval Date: 28 April 2022
  • Submission Classification: Type 2 - New Active Ingredient
  • Indication(s): Indicated for the treatment of adult patients with stable Wilson’s disease who are de-coppered and tolerant to penicillamine.
  • Approved Label: 28 April 2022 (PDF)