Most Read Articles
Stephen Padilla, 25 Jul 2019
Nonvitamin K antagonist oral anticoagulants (NOACs) appear to confer more clinical benefits to elderly patients with atrial fibrillation (AF) than vitamin K antagonist anticoagulants (VKAs), suggests a study, adding that this is primarily driven by the lower rates of major bleeding.
4 days ago
Older women with longer endogenous oestrogen exposure and hormone therapy use are at much higher odds of having favourable cognitive status in late life, a recent study suggests.
5 days ago
Multiple intralesional injections with purified protein derivative (PPD) leads to faster clearance of common warts compared with a single injection, although the latter is better tolerated, as shown in the results of an open‐label, superiority trial.
17 Oct 2019
Use of direct acting antivirals (DAAs) to treat hepatitis C virus (HCV) infection is feasible during pregnancy, as these drugs are highly effective and treatment duration is relatively short, according to a study. In addition, DAA treatment helps improve maternal health and prevent vertical transmission.

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
Stephen Padilla, 25 Jul 2019
Nonvitamin K antagonist oral anticoagulants (NOACs) appear to confer more clinical benefits to elderly patients with atrial fibrillation (AF) than vitamin K antagonist anticoagulants (VKAs), suggests a study, adding that this is primarily driven by the lower rates of major bleeding.
4 days ago
Older women with longer endogenous oestrogen exposure and hormone therapy use are at much higher odds of having favourable cognitive status in late life, a recent study suggests.
5 days ago
Multiple intralesional injections with purified protein derivative (PPD) leads to faster clearance of common warts compared with a single injection, although the latter is better tolerated, as shown in the results of an open‐label, superiority trial.
17 Oct 2019
Use of direct acting antivirals (DAAs) to treat hepatitis C virus (HCV) infection is feasible during pregnancy, as these drugs are highly effective and treatment duration is relatively short, according to a study. In addition, DAA treatment helps improve maternal health and prevent vertical transmission.