Most Read Articles
21 Aug 2019
Daily use of the selective oral Bruton’s tyrosine kinase inhibitor evobrutinib in the treatment of patients with relapsing multiple sclerosis helps reduce the number of gadolinium-enhancing lesions, according to the results of a phase II trial.
20 Aug 2019
The combination of pravastatin and sorafenib does not appear to improve survival in patients with hepatocellular carcinoma (HCC), a recent study has shown.
08 Jul 2017
Entecavir and lamivudine demonstrate comparable effects on the mortality rate of patients with chronic hepatitis B virus (HBV)-related acute exacerbation with or without acute-on-chronic liver failure (ACLF), reports a study. In patients with ACLF, however, entecavir delivers a more favourable long-term outcome and is associated with greater clinical improvements.
Roshini Claire Anthony, 20 Aug 2019

The combination of emtricitabine and dolutegravir with either a tenofovir alafenamide fumarate (TAF) or tenofovir disoproxil fumarate (TDF)-based regimen fared similarly to a TDF-emtricitabine-efavirenz regimen in reducing HIV-1 RNA levels, according to results of the phase III ADVANCE* study presented at IAS 2019.

Original New Drug Application Approvals by US FDA (16 - 31 May 2019)

31 May 2019
New drug applications approved by US FDA as of 16 - 31 May 2019 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.

NAYZILAM
  • Active Ingredient(s): Midazolam
  • Strength: 5 mg/0.5 mL
  • Dosage Form(s) / Route(s): Spray; nasal
  • Company: Proximagen, LLC
  • Approval Date: 17 May 2019
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizure) that are distinct from a patient's usual seizure pattern in patients with epilepsy 12 years of age and older. 
  • Approved Label17 May 2019 (PDF)

SLYND
  • Active Ingredient(s): Drospirenone
  • Strength: 4 mg
  • Dosage Form(s) / Route(s): Tablet; oral
  • Company: Exeltis USA, Inc.
  • Approval Date: 23 May 2019
  • Submission Classification: Type 2 - New Active Ingredient and Type 3 - New Dosage Form
  • Indication(s): Indicated for use by females of reproductive potential to prevent pregnancy. 
  • Approved Label23 May 2019 (PDF)

PIQRAY
  • Active Ingredient(s): Alpelisib
  • Strength: 50 mg; 150 mg; 200 mg
  • Dosage Form(s) / Route(s): Tablet; oral
  • Company: Novartis Pharms Corp
  • Approval Date: 24 May 2019
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer as detected by an FDA-approved test following progression on or after an endocrine-based regimen.
  • Approved Label24 May 2019 (PDF)
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Most Read Articles
21 Aug 2019
Daily use of the selective oral Bruton’s tyrosine kinase inhibitor evobrutinib in the treatment of patients with relapsing multiple sclerosis helps reduce the number of gadolinium-enhancing lesions, according to the results of a phase II trial.
20 Aug 2019
The combination of pravastatin and sorafenib does not appear to improve survival in patients with hepatocellular carcinoma (HCC), a recent study has shown.
08 Jul 2017
Entecavir and lamivudine demonstrate comparable effects on the mortality rate of patients with chronic hepatitis B virus (HBV)-related acute exacerbation with or without acute-on-chronic liver failure (ACLF), reports a study. In patients with ACLF, however, entecavir delivers a more favourable long-term outcome and is associated with greater clinical improvements.
Roshini Claire Anthony, 20 Aug 2019

The combination of emtricitabine and dolutegravir with either a tenofovir alafenamide fumarate (TAF) or tenofovir disoproxil fumarate (TDF)-based regimen fared similarly to a TDF-emtricitabine-efavirenz regimen in reducing HIV-1 RNA levels, according to results of the phase III ADVANCE* study presented at IAS 2019.