Original New Drug Application Approvals by US FDA (16 - 31 March 2020)

31 Mar 2020
Original New Drug Application Approvals by US FDA (16 - 31 March 2020)
New drug applications approved by US FDA as of 16 - 31 March 2020 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.

PULMOTECH MAA
  • Active Ingredient(s): Technetium TC99M albumin aggregated
  • Strength: 2 mg
  • Dosage Form(s) / Route(s): Injectable; injection
  • Company: CIS BIO Intl.
  • Approval Date: 20 March 2020
  • Submission Classification: Not available
  • Indication(s): Indicated for:
    • Lung scintigraphy as an adjunct in the evaluation of pulmonary perfusion in adult and pediatric patients.
    • Scintigraphy of peritoneovenous shunt as an aid in the evaluation of its patency in adults.
  • Approved Label: 20 March 2020 (PDF)

ZEPOSIA
  • Active Ingredient(s): Ozanimod hydrochloride
  • Strength: 0.23 mg; 0.46 mg; 0.92 mg
  • Dosage Form(s) / Route(s): Capsule; oral
  • Company: Celgene
  • Approval Date: 25 March 2020
  • Submission Classification: Type 1 - New Molecular Entity
  • 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: 25 March 2020 (PDF)

TRIFERIC
  • Active Ingredient(s): Ferric pyrophosphate citrate
  • Strength: 6.75 mg iron per 4.5 mL solution
  • Dosage Form(s) / Route(s): Solution; intravenous
  • Company: Rockwell Medical Inc.
  • Approval Date: 27 March 2020
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for the replacement of iron to maintain hemoglobin in adult patients with hemodialysis-dependent chronic kidney disease (HDD-CKD).
  • Approved Label: 27 March 2020 (PDF)

LEVONORGESTREL AND ETHINYL ESTRADIOL
  • Active Ingredient(s): Ethinyl estradiol; levonorgestrel
  • Strength: 0.01 mg/0.02 mg
  • Dosage Form(s) / Route(s): Tablet; oral
  • Company: Exeltis USA, Inc.
  • Approval Date: 30 March 2020
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Not available
  • Approved Label: Not available