Original New Drug Application Approvals by US FDA (16-31 October 2021)

07 Nov 2021
Original New Drug Application Approvals by US FDA (16-31 October 2021)
New drug applications approved by US FDA as of 16-31 October 2021 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.

XIPERE
  • Active Ingredient(s): Triamcinolone Acetonide
  • Strength: 40MG/ML
  • Dosage Form(s) / Route(s): Injectable; Suspension
  • Company: Clearside Biomedical, Inc
  • Approval Date: 22 October 2021
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for the treatment of macular edema associated with uveitis.
  • Approved Label22 October 2021 (PDF)
SUSVIMO
  • Active Ingredient(s): Ranibizumab
  • Strength: 100MG/ML
  • Dosage Form(s) / Route(s): Solution; Injection
  • Company: Genentech Inc
  • Approval Date: 22 October 2021
  • Submission Classification:Not available
  • Indication(s): Indicated for the treatment of patients with Neovascular (wet) Age-related Macular Degeneration (AMD) who have previously responded to at least two intravitreal injections of a VEGF inhibitor 
  • Approved Label22 October 2021 (PDF)
VUITY
  • Active Ingredient(s): Pilocarpine Hydrochloride
  • Strength: 1.25%
  • Dosage Form(s) / Route(s): Solution/drops; Ophthalmic
  • Company: Abbvie Inc
  • Approval Date: 28 October 2021
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for the treatment of presbyopia in adults.
  • Approved Label28 October 2021 (PDF)
DILTIAZEM HYDROCHLORIDE
  • Active Ingredient(s): Diltiazem Hydrochloride
  • Strength: 125MG/125ML (1MG/ML); 250MG/250ML (1MG/1ML)
  • Dosage Form(s) / Route(s): Solution; Intravenous
  • Company: Exela Pharma
  • Approval Date: 28 October 2021
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for the following:
    • Temporary control of rapid ventricular rate in atrial fibrillation or atrial flutter.
    • Rapid conversion of paroxysmal supraventricular tachycardias (PSVT) to sinus rhythm.
  • Approved Label28 October 2021 (PDF)
SCEMBLIX
  • Active Ingredient(s): Asciminib
  • Strength: 20MG; 40MG
  • Dosage Form(s) / Route(s): Tablet; Oral
  • Company: Novartis Pharms Corp
  • Approval Date: 29 October 2021
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of adult patients with:
    • Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP), previously treated with two or more tyrosine kinase inhibitors (TKIs). This indication is approved under accelerated approval based on major molecular response (MMR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
    • Ph+ CML in CP with the T315I mutation
  • Approved Label29 October 2021 (PDF)
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