Most Read Articles
3 days ago
Combining the DASH (Dietary Approaches to Stop Hypertension) diet with low sodium intake reduces systolic blood pressure (SBP) in individuals with pre- and stage 1 hypertension, with progressively higher reductions at greater levels of baseline SBP, a recent study has shown.
5 days ago
Cognitive deficits in bipolar disorder are neurodevelopmental rather than neurodegenerative in nature, a recent study has reported. Furthermore, cognitive impairment in bipolar patients appears to be stable, in the majority at least.
2 days ago
Tadalafil may not be effective for reducing the decline in ambulatory ability in boys with Duchenne muscular dystrophy (DMD), as shown in a recent study.
5 days ago
Hydrochlorothiazide (HCTZ) appears to significantly increase the risks of nonmelanoma skin cancer (NMSC), particularly squamous cell carcinoma (SCC), a recent study has shown.

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
3 days ago
Combining the DASH (Dietary Approaches to Stop Hypertension) diet with low sodium intake reduces systolic blood pressure (SBP) in individuals with pre- and stage 1 hypertension, with progressively higher reductions at greater levels of baseline SBP, a recent study has shown.
5 days ago
Cognitive deficits in bipolar disorder are neurodevelopmental rather than neurodegenerative in nature, a recent study has reported. Furthermore, cognitive impairment in bipolar patients appears to be stable, in the majority at least.
2 days ago
Tadalafil may not be effective for reducing the decline in ambulatory ability in boys with Duchenne muscular dystrophy (DMD), as shown in a recent study.
5 days ago
Hydrochlorothiazide (HCTZ) appears to significantly increase the risks of nonmelanoma skin cancer (NMSC), particularly squamous cell carcinoma (SCC), a recent study has shown.