Original New Drug Application Approvals by US FDA (16 - 30 April 2020)

29 Apr 2020
Original New Drug Application Approvals by US FDA (16 - 30 April 2020)
New drug applications approved by US FDA as of 16 - 30 April 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.

EMERPHED
  • Active Ingredient(s): Ephedrine sulfate
  • Strength: 50 mg/10 mL
  • Dosage Form(s) / Route(s): Injectable; injection
  • Company: Nexus Pharms
  • Approval Date: 17 April 2020
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia.
  • Approved Label17 April 2020 (PDF)

TUKYSA
  • Active Ingredient(s): Tucatinib
  • Strength: 50 mg
  • Dosage Form(s) / Route(s): Tablet; oral
  • Company: Seattle Genetics
  • Approval Date: 17 April 2020
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated in combination with trastuzumab and capecitabine for treatment of adult patients with advanced unresectable  or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting.
  • Approved Label17 April 2020 (PDF)

PEMAZYRE
  • Active Ingredient(s): Pemigatinib
  • Strength: 4.5 mg; 9 mg; 13.5 mg
  • Dosage Form(s) / Route(s): Tablet; oral
  • Company: Incyte Corp.
  • Approval Date: 17 April 2020
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of adults with previously treated, unresectable locally advances or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test.
  • Approved Label17 April 2020

TRODELVY
  • Active Ingredient(s): Sacituzumab govitecan-hziy
  • Strength: 180 mg
  • Dosage Form(s) / Route(s): Injectable; injection
  • Company: Immuomedics, Inc.
  • Approval Date: 22 April 2020
  • Submission Classification: Not available
  • Indication(s): Indicated for treatment of adult patients with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies for metastatic disease.
  • Approved Label22 April 2020 (PDF)

ONGENTYS
  • Active Ingredient(s): Opicapone
  • Strength: 25 mg; 50 mg
  • Dosage Form(s) / Route(s): Capsule; oral
  • Company: Neurocrine
  • Approval Date: 24 April 2020
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated as adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease (PD) experiencing "off" episodes.
  • Approved Label24 April 2020 (PDF)

MILPROSA
  • Active Ingredient(s): Progesterone
  • Strength: 1.78 g
  • Dosage Form(s) / Route(s): Ring; vaginal
  • Company: Ferring Pharmaceutical, Inc.
  • Approval Date: 29 April 2020
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated to support embryo implantation and early pregnancy (up to 10 weeks post-embryo transfer) by supplementation of corpus luteal function as part of an Assisted Reproductive Technology (ART) treatment program for infertile women.
  • Approved Label29 April 2020 (PDF)
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