Most Read Articles
Roshini Claire Anthony, 02 Feb 2018

The use of weight loss medications for at least 1 year did little to improve cardiometabolic risk factors in obese adults, according to a systematic review and meta-analysis.

17 Feb 2019
In patients with type 2 diabetes (T2D), sodium-glucose cotransporter 2 (SGLT2) inhibitor monotherapy, particularly canagliflozin, exerts greater effects on weight compared with metformin and dipeptidyl peptidase 4 (DPP-4) inhibitors or gliptins, according to the results of a meta-analysis.
26 Feb 2019
Oral fluoxetine confers beneficial effects in the management of adult and adolescent amblyopia, suggests a recent study.
19 Feb 2019
Preprandial administration of metformin successfully and safely reduces postprandial plasma triglyceride levels, a new study has shown.

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
Roshini Claire Anthony, 02 Feb 2018

The use of weight loss medications for at least 1 year did little to improve cardiometabolic risk factors in obese adults, according to a systematic review and meta-analysis.

17 Feb 2019
In patients with type 2 diabetes (T2D), sodium-glucose cotransporter 2 (SGLT2) inhibitor monotherapy, particularly canagliflozin, exerts greater effects on weight compared with metformin and dipeptidyl peptidase 4 (DPP-4) inhibitors or gliptins, according to the results of a meta-analysis.
26 Feb 2019
Oral fluoxetine confers beneficial effects in the management of adult and adolescent amblyopia, suggests a recent study.
19 Feb 2019
Preprandial administration of metformin successfully and safely reduces postprandial plasma triglyceride levels, a new study has shown.