Most Read Articles
Roshini Claire Anthony, 3 days ago

The presence of pulmonary arterial hypertension (PAH) in individuals with systemic sclerosis is associated with an increased mortality risk, a study from Singapore showed.

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.
Stephen Padilla, 6 days ago
Brodalumab has exhibited long-term efficacy and consistent safety profile for more than 2 years in the treatment of patients with psoriasis, results of the phase III AMAGINE-2 trial show.
19 Jan 2020
Anaemia increases mortality risk in heart failure (HF) patients across the ejection fraction (EF) spectrum, a recent study has found. The effect appears to be stronger in preserved (HFpEF) and midrange (HFmrEF) than in reduced (HFrEF) EF disease.

Original New Drug Application Approvals by US FDA (16 - 31 January 2019)

31 Jan 2019
New drug applications approved by US FDA as of 16 - 31 January 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.

ONTRUZANT
  • Active Ingredient(s): Trastuzumab-dttb
  • Strength: 150 MG
  • Dosage Form(s) / Route(s): Injectable; Injection
  • Company: Samsung Bioepis Co Ltd
  • Approval Date: 18 Jan 2019
  • Submission Classification: Not available
  • Indication(s): Indicated for:
    • The treatment of HER2-overexpressing breast cancer.
    • The treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.
  • Approved Label: 18 Jan 2019 (PDF)
TOSYMRA
  • Active Ingredient(s): Sumatriptan
  • Strength: 10 MG
  • Dosage Form(s) / Route(s): Spray; Nasal
  • Company: Dr Reddy's Labs Ltd
  • Approval Date: 25 Jan 2019
  • Submission Classification:  Type 3 - New Dosage Form
  • Indication(s): Indicated for the acute treatment of migraine with or without aura in adults.
  • Approved Label: 25 Jan 2019 (PDF)
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Most Read Articles
Roshini Claire Anthony, 3 days ago

The presence of pulmonary arterial hypertension (PAH) in individuals with systemic sclerosis is associated with an increased mortality risk, a study from Singapore showed.

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.
Stephen Padilla, 6 days ago
Brodalumab has exhibited long-term efficacy and consistent safety profile for more than 2 years in the treatment of patients with psoriasis, results of the phase III AMAGINE-2 trial show.
19 Jan 2020
Anaemia increases mortality risk in heart failure (HF) patients across the ejection fraction (EF) spectrum, a recent study has found. The effect appears to be stronger in preserved (HFpEF) and midrange (HFmrEF) than in reduced (HFrEF) EF disease.