Most Read Articles
Pearl Toh, 27 Mar 2020
Every-two-month injections of the long-acting cabotegravir + rilpivirine were noninferior to once-monthly injections for virologic suppression at 48 weeks in people living with HIV*, according to the ATLAS-2M** study presented at CROI 2020 — thus providing a potential option with more convenient dosing.
Stephen Padilla, 31 Mar 2020
Treatment with hydroxychloroquine appears to significantly reduce viral load in patients with the novel coronavirus disease (COVID-19), with its beneficial effects reinforced by adding azithromycin, results of a recent study have shown.
Elvira Manzano, 22 Nov 2017
A blood pressure (BP) reading of 130/80 mm Hg or higher is the ‘new high’ in the latest AHA/ACC* hypertension guidelines, a threshold that is tighter than the JNC 7** cutpoint of 140/90 mm Hg for stage 1 hypertension in the general population. The change will mean more patients being labelled with hypertension.
Audrey Abella, 27 Mar 2020
The angiotensin receptor blocker (ARB) losartan did not improve inflammation, T-cell immune recovery, or fibrotic activity among older persons living with HIV (PLHIV) and viral suppression, according to data presented at CROI 2020.

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
Pearl Toh, 27 Mar 2020
Every-two-month injections of the long-acting cabotegravir + rilpivirine were noninferior to once-monthly injections for virologic suppression at 48 weeks in people living with HIV*, according to the ATLAS-2M** study presented at CROI 2020 — thus providing a potential option with more convenient dosing.
Stephen Padilla, 31 Mar 2020
Treatment with hydroxychloroquine appears to significantly reduce viral load in patients with the novel coronavirus disease (COVID-19), with its beneficial effects reinforced by adding azithromycin, results of a recent study have shown.
Elvira Manzano, 22 Nov 2017
A blood pressure (BP) reading of 130/80 mm Hg or higher is the ‘new high’ in the latest AHA/ACC* hypertension guidelines, a threshold that is tighter than the JNC 7** cutpoint of 140/90 mm Hg for stage 1 hypertension in the general population. The change will mean more patients being labelled with hypertension.
Audrey Abella, 27 Mar 2020
The angiotensin receptor blocker (ARB) losartan did not improve inflammation, T-cell immune recovery, or fibrotic activity among older persons living with HIV (PLHIV) and viral suppression, according to data presented at CROI 2020.