Most Read Articles
11 Aug 2020
During the Allergic Rhinitis (AR) Boot Camp held in conjunction with the Bayer Pharmacist Congress 2020, Professor Dr Baharudin Abdullah discussed the management of AR in the primary care setting and the importance of using patient profiles to guide the choice of antihistamines.
Elaine Soliven, 4 days ago
Adding mepolizumab to standard of care treatment significantly reduces nasal polyp size and obstruction in adults with chronic rhinosinusitis with nasal polyps (CRSwNP), according to the SYNAPSE* study presented at ERS 2020.
6 days ago
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Audrey Abella, 11 Sep 2020
A prasugrel de-escalation strategy significantly reduced the risk of NACE* and bleeding events in patients with ACS** after PCI*** compared with the conventional strategy, results of the HOST-REDUCE-POLYTECH-ACS# trial have shown.

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
11 Aug 2020
During the Allergic Rhinitis (AR) Boot Camp held in conjunction with the Bayer Pharmacist Congress 2020, Professor Dr Baharudin Abdullah discussed the management of AR in the primary care setting and the importance of using patient profiles to guide the choice of antihistamines.
Elaine Soliven, 4 days ago
Adding mepolizumab to standard of care treatment significantly reduces nasal polyp size and obstruction in adults with chronic rhinosinusitis with nasal polyps (CRSwNP), according to the SYNAPSE* study presented at ERS 2020.
6 days ago
OZEMPIC – Semaglutide 1.34 mg/mL soln for inj
Audrey Abella, 11 Sep 2020
A prasugrel de-escalation strategy significantly reduced the risk of NACE* and bleeding events in patients with ACS** after PCI*** compared with the conventional strategy, results of the HOST-REDUCE-POLYTECH-ACS# trial have shown.