Most Read Articles
Roshini Claire Anthony, 05 Oct 2017

Olfactory impairment in older adults may point to an elevated risk of developing Parkinson’s disease (PD), particularly in Caucasian men, a small US study found.

07 Oct 2017
Women who follow a low-fat dietary pattern appear to have reduced breast cancer mortality, according to data from the Earlier Women’s Health Initiative Dietary Modification trial.
Pearl Toh, 4 days ago
Women with higher plasma tryptophan concentrations were less likely to have poor sleep quality during pregnancy, especially among those with anxiety symptoms, according to the GUSTO* study.
6 days ago
Blood glucose testing every other day in patients with controlled gestational diabetes mellitus (GDM) resulted in higher testing compliance than every day testing, a new 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
Roshini Claire Anthony, 05 Oct 2017

Olfactory impairment in older adults may point to an elevated risk of developing Parkinson’s disease (PD), particularly in Caucasian men, a small US study found.

07 Oct 2017
Women who follow a low-fat dietary pattern appear to have reduced breast cancer mortality, according to data from the Earlier Women’s Health Initiative Dietary Modification trial.
Pearl Toh, 4 days ago
Women with higher plasma tryptophan concentrations were less likely to have poor sleep quality during pregnancy, especially among those with anxiety symptoms, according to the GUSTO* study.
6 days ago
Blood glucose testing every other day in patients with controlled gestational diabetes mellitus (GDM) resulted in higher testing compliance than every day testing, a new study has shown.