Most Read Articles
05 Nov 2019
Low total cholesterol levels appear to carry increased major adverse cardiovascular events (MACE) hazard in older men without ischaemic heart disease (IHD) and not receiving statin therapy but not to those on statins, according to data from the CHAMP (Concord Health and Ageing in Men Project) cohort.
2 days ago
Better sleep appears to weaken pain and fatigue in older, community-dwelling adults with hip or knee osteoarthritis (OA), reports a recent study.
6 days ago
Maribavir 400 mg twice daily appears to have comparable efficacy to valganciclovir at clearing cytomegalovirus viraemia in transplant recipients, a study has found.
5 days ago
Individuals with and without gout appear to have a similar risk of developing colorectal cancer, suggesting that gout does not contribute to a risk increase, a study has found.

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
05 Nov 2019
Low total cholesterol levels appear to carry increased major adverse cardiovascular events (MACE) hazard in older men without ischaemic heart disease (IHD) and not receiving statin therapy but not to those on statins, according to data from the CHAMP (Concord Health and Ageing in Men Project) cohort.
2 days ago
Better sleep appears to weaken pain and fatigue in older, community-dwelling adults with hip or knee osteoarthritis (OA), reports a recent study.
6 days ago
Maribavir 400 mg twice daily appears to have comparable efficacy to valganciclovir at clearing cytomegalovirus viraemia in transplant recipients, a study has found.
5 days ago
Individuals with and without gout appear to have a similar risk of developing colorectal cancer, suggesting that gout does not contribute to a risk increase, a study has found.