Most Read Articles
Pearl Toh, 31 Dec 2019
Adding the neuraminidase inhibitor oseltamivir to usual care speeds up recovery from influenza-like illness by a day compared with usual care alone, with even greater benefits seen in older, sicker patients with comorbidities, according to the ALIC4E study.
23 Dec 2019
At a Menarini-sponsored symposium held during the Asian Pacific Society Congress, renowned cardiologist Prof John Camm provided the latest evidence for chronic stable angina with or without concomitant diseases, with a special focus on the antianginal agent ranolazine and combination therapies. The event was chaired and moderated by Dr Dante Morales from the University of the Philippines College of Medicine.
Pearl Toh, 13 Jan 2020
Obeticholic acid significantly improves fibrosis and disease activity in patients with nonalcoholic steatohepatitis (NASH), a chronic liver disease currently with no approved therapy, according to an interim analysis of the landmark REGENERATE* study.
Stephen Padilla, 6 days ago
The Lancet Commission on Hypertension Group has recently released a position statement that contains a list of recommendations for the improvement of accuracy standards for devices that measure blood pressure (BP).

Original New Drug Application Approvals by US FDA (16 - 31 May 2017)

31 May 2017
New drug applications approved by US FDA as of 16 - 31 May 2017 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.

JADENU SPRINKLE
  • Active Ingredient(s): DEFERASIROX
  • Strength: 90MG; 180MG
  • Dosage Form: Oral granule
  • Company: Novartis Pharms Corp
  • Approval Date: May 18, 2017
  • Chemical Type: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for
    • the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older
    • the treatment of chronic iron overload in patients 10 years of age and older with non-transfusion-dependent thalassemia (NTDT) syndromes and with a liver iron (Fe) concentration (LIC) of at least 5 mg Fe per gram of dry weight (Fe/g dw) and a serum ferritin greater than 300 mcg/L
  • Approved Label: 05/18/2017 (PDF)

KEVZARA
  • Active Ingredient(s): SARILUMAB
  • Strength: 150MG/1.14ML; 200MG/1.14ML
  • Dosage Form: Injectable; Injection
  • Company: Sanofi Synthelabo
  • Approval Date: May 22, 2017
  • Chemical Type: Not available
  • Indication(s): Indicated for treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs).
  • Approved Label: 05/22/2017 (PDF)

ZERVIATE
  • Active Ingredient(s): CETIRIZINE HYDROCHLORIDE
  • Strength: EQ 0.24% BASE
  • Dosage Form: Ophthalmic solution/drops
  • Company: Nicox Ophthalmics
  • Approval Date: May 30, 2017
  • Chemical Type: Type 3 - New Dosage Form
  • Indication(s): Indicated for treatment of ocular itching associated with allergic conjunctivitis
  • Approved Label: 05/30/2017 (PDF)
Editor's Recommendations
Most Read Articles
Pearl Toh, 31 Dec 2019
Adding the neuraminidase inhibitor oseltamivir to usual care speeds up recovery from influenza-like illness by a day compared with usual care alone, with even greater benefits seen in older, sicker patients with comorbidities, according to the ALIC4E study.
23 Dec 2019
At a Menarini-sponsored symposium held during the Asian Pacific Society Congress, renowned cardiologist Prof John Camm provided the latest evidence for chronic stable angina with or without concomitant diseases, with a special focus on the antianginal agent ranolazine and combination therapies. The event was chaired and moderated by Dr Dante Morales from the University of the Philippines College of Medicine.
Pearl Toh, 13 Jan 2020
Obeticholic acid significantly improves fibrosis and disease activity in patients with nonalcoholic steatohepatitis (NASH), a chronic liver disease currently with no approved therapy, according to an interim analysis of the landmark REGENERATE* study.
Stephen Padilla, 6 days ago
The Lancet Commission on Hypertension Group has recently released a position statement that contains a list of recommendations for the improvement of accuracy standards for devices that measure blood pressure (BP).