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- 30 September 2017)

30 Sep 2017
New drug applications approved by US FDA as of 16 - 30 September 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.

XHANCE
  • Active Ingredient(s): FLUTICASONE PROPIONATE
  • Strength: 93MCG
  • Dosage Form: Nasal spray
  • Company: Optnose US Inc
  • Approval Date: September 18, 2017
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Not available
  • Approved Label: Not available

TRELEGY ELLIPTA
  • Active Ingredient(s): FLUTICASONE FUROATE;UMECLIDINIUM;VILANTEROL
  • Strength: 100MCG;62.5MCG;25MCG
  • Dosage Form: Inhalation powder
  • Company: Glaxosmithkline
  • Approval Date: September 18, 2017
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for the long-term, once-daily, maintenance treatment of patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema, who are on a fixed-dose combination of fluticasone furoate and vilanterol for airflow obstruction and reducing exacerbations in whom additional treatment of airflow obstruction is desired or for patients who are already receiving umeclidinium and a fixed-dose combination of fluticasone furoate and vilanterol
  • Approved Label: 09/18/2017 (PDF)

CLOROTEKAL
  • Active Ingredient(s): CHLOROPROCAINE HYDROCHLORIDE
  • Strength: 1%(10MG/ML)
  • Dosage Form: Injectable; Injection
  • Company: Sintetica SA
  • Approval Date: September 26, 2017
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for intrathecal injection in adults for the production of subarachnoid block (spinal anesthesia)
  • Approved Label: 09/26/2017 (PDF)

VERZENIO
  • Active Ingredient(s): ABEMACICLIB
  • Strength: 50MG | 100MG | 150MG | 200MG
  • Dosage Form: Oral tablet
  • Company: Eli Lilly and Co
  • Approval Date: September 28, 2017
  • Submission Classification: Not available
  • Indication(s): Indicated:
    • in combination with fulvestrant for the treatment of women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy
    • as monotherapy for the treatment of adult patients with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting
  • Approved Label: 09/28/2017 (PDF)
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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).