Most Read Articles
Roshini Claire Anthony, 17 Sep 2020

In patients with osteoporosis treated with denosumab, a long interval between injections could raise their risk of vertebral fracture, a UK-based retrospective study showed.

Roshini Claire Anthony, 09 Oct 2020

The risk of falls and subsequent injuries (eg, fractures) may be elevated in individuals with diabetes compared with the general population, according to a nationwide cohort study from Denmark.

Rachel Soon, 28 Aug 2020
MOH Director-General Tan Sri Dato' Seri Dr Noor Hisham Abdullah speaks about NHMS 2019 and pharmacists' roles in combating NCDs among Malaysians.
02 Jul 2019
A systematic review has recently described the rudimentary pharmacokinetics of mitragynine, but studies lack information on the role of metabolism and redistribution into tissues or excretion rate.

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
Roshini Claire Anthony, 17 Sep 2020

In patients with osteoporosis treated with denosumab, a long interval between injections could raise their risk of vertebral fracture, a UK-based retrospective study showed.

Roshini Claire Anthony, 09 Oct 2020

The risk of falls and subsequent injuries (eg, fractures) may be elevated in individuals with diabetes compared with the general population, according to a nationwide cohort study from Denmark.

Rachel Soon, 28 Aug 2020
MOH Director-General Tan Sri Dato' Seri Dr Noor Hisham Abdullah speaks about NHMS 2019 and pharmacists' roles in combating NCDs among Malaysians.
02 Jul 2019
A systematic review has recently described the rudimentary pharmacokinetics of mitragynine, but studies lack information on the role of metabolism and redistribution into tissues or excretion rate.