Original New Drug Application Approvals by US FDA (01 - 15 December 2019)

17 Dec 2019
Original New Drug Application Approvals by US FDA (01 - 15 December 2019)
New drug applications approved by US FDA as of 01 - 15 December 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.

AVSOLA
  • Active Ingredient(s): Infliximab-axxq
  • Strength: 100 mg/vial
  • Dosage Form(s) / Route(s): Injectable; injection
  • Company: Amgen, Inc.
  • Approval Date: 06 December 2019
  • Submission Classification: Not available
  • Indication(s): Indicated for:
    • Crohn's Disease: reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy; reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing disease.
    • Pediatric Crohn's Disease: reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients with moderately to severely active disease who have had an inadequate response to conventional therapy.
    • Ulcerative Colitis: reducing signs and symptoms, inducing and maintaining clinical remission and mucosal healing, and eliminating corticosteroid use in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy.
    • Pediatric Ulcerative Colitis: reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients with moderately to severely active disease who have had an inadequate response to conventional therapy.
    • Rheumatoid Arthritis in combination with methotrexate: reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active disease.
    • Ankylosing Spondylitis: reducing signs and symptoms in patients with active disease.
    • Psoriatic Arthritis: reducing signs and symptoms of active arthritis, inhibiting the progression of structural damage, and improving physical function.
    • Plaque Psoriasis: treatment of adult patients with chronic severe (i.e., extensive and/or disabling) plaque psoriasis who are candidates for systemic therapy and when other systemic therapies are medically less appropriate.
  • Approved Label: 06 December 2019 (PDF)

VYONDYS 53
  • Active Ingredient(s): Golodirsen
  • Strength: 50 mg/mL
  • Dosage Form(s) / Route(s): Solution; intravenous
  • Company: Sarepta Therapeutics Inc.
  • Approval Date: 12 December 2019
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 53 skipping. This indication is approved under accelerated approval based on an increase in dystrophin production in skeletal muscle observed in patients treated with VYONDYS 53. Continued approval for this indication may be contingent upon verification of a clinical benefit in confirmatory trials.
  • Approved Label: 12 December 2019 (PDF)

NOURESS
  • Active Ingredient(s): Cysteine hydrochloride
  • Strength: 50 mg/mL
  • Dosage Form(s) / Route(s): Injectable; injection
  • Company: Avadel Legacy
  • Approval Date: 13 December 2019
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for use as an additive to amino acids solutions to meet nutritional requirements of neonates (preterm and term infants less than one month of age) requiring total parenteral nutrition. 
  • Approved Label: 13 December 2019 (PDF)