Original New Drug Application Approvals by US FDA (01 - 15 August 2020)

New drug applications approved by US FDA as of 01 - 15 August 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.

VASOPRESSIN

• Active Ingredient(s): Vasopressin
• Strength: 20 units/mL
• Dosage Form(s) / Route(s): Solution; intravenous
• Company: American Regent, Inc.
• Approval Date: 03 August 2020
• Submission Classification: Type 7 - Drug Already Marketed without Approved NDA
• Indication(s): Indicated to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines.
• Approved Label: 03 August 2020 (PDF)

XTANDI

• Active Ingredient(s): Enzalutamide
• Strength: 40 mg; 80 mg
• Dosage Form(s) / Route(s): Tablet, film coated
• Company: Astellas
• Approval Date: 04 August 2020
• Submission Classification: Type 3 - New Dosage Form
• Indication(s): Indicated for the treatment of patients with:
• castration-resistant prostate cancer.
• metastatic castration-sensitive prostate cancer.
• Approved Label: 04 August 2020 (PDF)

BLENREP

• Active Ingredient(s): Belantamab mafodotin-blmf
• Strength: 2.5 mg/kg
• Dosage Form(s) / Route(s): Injectable; intravenous
• Company: GlaxoSmithKline
• Approval Date: 05 August 2020
• Submission Classification: Not available
• Indication(s): Indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least 4 prior therapies including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent.
• Approved Label: 05 August 2020 (PDF)

LAMPIT

• Active Ingredient(s): Nifurtimox
• Strength: 30 mg; 120 mg
• Dosage Form(s) / Route(s): Tablet; oral
• Company: Bayer Healthcare Pharms
• Approval Date: 06 August 2020
• Submission Classification: Type 1 - New Molecular Entity
• Indication(s): Indicated in pediatric patients (birth to less than 18 years of age and weighing at least 2.5 kg) for the treatment of Chagas disease (American Trypanosomiasis), caused by Trypanosoma cruzi.
• Approved Label: 06 August 2020 (PDF)

OLINVYK

• Active Ingredient(s): Oliceridine
• Strength: 1.5 mg
• Dosage Form(s) / Route(s): Injectable; intravenous
• Company: Trevena, Inc.
• Approval Date: 07 August 2020
• Submission Classification: Type 1 - New Molecular Entity
• Indication(s): Indicated in adults for the management of acute pain severe enough to required an intravenous opioid analgesic and for whom alternative treatments are inadequate.
• Approved Label: 07 August 2020 (PDF)

EVRYSDI

• Active Ingredient(s): Risdiplam
• Strength: 1.5 mg
• Dosage Form(s) / Route(s): Powder for oral solution
• Company: Genentech, Inc.
• Approval Date: 07 August 2020
• Submission Classification: Type 1 - New Molecular Entity
• Indication(s): Indicated for the treatment of spinal muscular atrophy (SMA) in patients 2 months of age and older.
• Approved Label: 07 August 2020 (PDF)

VILTEPSO

• Active Ingredient(s): Viltolarsen
• Strength: 250 mg/5 mL
• Dosage Form(s) / Route(s): Injectable; injection
• Company: Nippon Shinyaku Co., Ltd.
• Approval Date: 12 August 2020
• 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.
• Approved Label: 12 August 2020 (PDF)

ENSPRYNG

• Active Ingredient(s): Satralizumab
• Strength: 120 mg/mL
• Dosage Form(s) / Route(s): Injectable; injection
• Company: Genentech
• Approval Date: 14 August 2020
• Submission Classification: Not available
• Indication(s): Indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.
• Approved Label: 14 August 2020 (PDF)