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

18 Aug 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 Label03 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 Label04 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 Label05 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 Label06 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 Label07 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 Label07 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 Label12 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 Label14 August 2020 (PDF)
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Most Read Articles
Audrey Abella, 10 Sep 2020
Interim results of REGENERATE* trial highlight the ability of experimental noninvasive tests to evaluate treatment response in adults with NASH** and advanced liver fibrosis who are receiving obeticholic acid (OCA).
27 Sep 2019
Quadrivalent influenza vaccine (split virion, inactivated) 0.5 mL inj
Jairia Dela Cruz, 23 Sep 2020
The combination of pitavastatin and fenofibrate appears to have superior effect on non-high-density lipoprotein cholesterol (non–HDL-C), as well as other lipids, compared with a statin alone in high-risk patients with mixed dyslipidemia, according to a study.
Stephen Padilla, 17 Dec 2019
The use of aspirin for primary prevention in patients without known cardiovascular diseases (CVDs) significantly reduces the risk of myocardial infarction (MI) but increases that of major bleeding and haemorrhagic stroke, according to a meta-analysis.