Original New Drug Application Approvals by US FDA (16 - 31 October 2019)

31 Oct 2019
Original New Drug Application Approvals by US FDA (16 - 31 October 2019)
New drug application approved by US FDA as of 16 - 31 October 2019 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.

AMZEEQ
  • Active Ingredient(s): Minocycline
  • Strength: 4%
  • Dosage Form(s) / Route(s):Aerosol, foam; topical
  • Company: Foamix Pharma, Inc.
  • Approval Date: 18 October 2019
  • Submission Classification: Not available
  • Indication(s): Indicated to treat inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older.
  • Approved Label: 18 October 2019 (PDF)

TRIKAFTA
  • Active Ingredient(s): Elexacaftor, tezacaftor, ivacaftor; ivacaftor
  • Strength: 100 mg, 75 mg, 50 mg; 150 mg
  • Dosage Form(s) / Route(s): Tablet; oral
  • Company: Vertex Pharms, Inc.
  • Approval Date: 21 October 2019
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of cystic fibrosis (CF) in patients aged 12 years and older who have at least one F508del mutation in the CFTR gene. If the patients's genotype is unknown, an FDA-cleared CF mutation test should be used to confirm the presence of at least one F508del mutation.
  • Approved Label: 21 October 2019 (PDF)

BIORPHEN
  • Active Ingredient(s): Phenylephrine hydrochloride
  • Strength: 0.1 mg/mL
  • Dosage Form(s) / Route(s): Injectable; injection
  • Company: Sintetica SA
  • Approval Date: 21 October 2019
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia.
  • Approved Label: 21 October 2019 (PDF)

VUMERITY
  • Active Ingredient(s): Diroximel fumarate
  • Strength: 231 mg
  • Dosage Form(s) / Route(s): Capsule, delayed release; oral
  • Company: Alkermes
  • Approval Date: 29 October 2019
  • Submission Classification: Type 2 - New Active Ingredient
  • Indication(s): Indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. 
  • Approved Label: 29 October 2019 (PDF)