Most Read Articles
21 Jun 2016
Sofosbuvir-based regimens showed good cost-effectiveness in a majority of patients suffering from chronic hepatitis C, as observed in a systematic review of fourteen studies conducted in seven different countries.
14 May 2019
At the recent GLYCEMIC GUARDIANS™ dinner symposium, three eminent speakers spoke on theindispensable role of medical nutrition therapy (MNT) in improving outcomes for patients with type2 diabetes (T2D).
Yesterday
Treatment with water-free cyclosporine formulation at either 0.1% or 0.05% concentration is tolerable and provides effective relief of the signs of dry eye disease, according to data from a phase II study.
4 days ago
New drug applications approved by US FDA as of 01 - 15 June 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. 

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 Jun 2016
Sofosbuvir-based regimens showed good cost-effectiveness in a majority of patients suffering from chronic hepatitis C, as observed in a systematic review of fourteen studies conducted in seven different countries.
14 May 2019
At the recent GLYCEMIC GUARDIANS™ dinner symposium, three eminent speakers spoke on theindispensable role of medical nutrition therapy (MNT) in improving outcomes for patients with type2 diabetes (T2D).
Yesterday
Treatment with water-free cyclosporine formulation at either 0.1% or 0.05% concentration is tolerable and provides effective relief of the signs of dry eye disease, according to data from a phase II study.
4 days ago
New drug applications approved by US FDA as of 01 - 15 June 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.