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 Label: 17 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 Label: 17 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 Label: 17 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 Label: 22 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 Label: 24 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 Label: 29 April 2020 (PDF)