Most Read Articles
Roshini Claire Anthony, 4 days ago

The combined use of piperacillin and tazobactam does not appear to be a suitable alternative to meropenem for patients with bloodstream infections caused by ceftriaxone-resistant Escherichia coli (E. coli) or Klebsiella pneumoniae (K. pneumoniae), according to results of the MERINO* trial.

Tristan Manalac, 19 May 2018
Taking oral antibiotics appears to increase the risk of nephrolithiasis, according to a recent study. Moreover, the risk seems to be compounded for individuals with recent antibiotic exposure and those who were exposed at a younger age.
2 days ago
Patients with inflammatory bowel disease are at increased risk of developing acute myocardial infarction (AMI) or heart failure, although the prevalence of traditional risk factors for such cardiovascular disorders appears to be low, as reported in a recent study.
3 days ago
Early renin-angiotensin-aldosterone system (RAAS) blockade with renin-angiotensin system inhibitors (RASI) leads to better short- and long-term renal outcomes in systemic lupus erythematosus (SLE) patients with antiphospholipid-associated nephropathy (aPLN), according to a study, adding that this renal protective effect is independent of RASI’s antihypertensive and antiproteinuric effects.

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, 4 days ago

The combined use of piperacillin and tazobactam does not appear to be a suitable alternative to meropenem for patients with bloodstream infections caused by ceftriaxone-resistant Escherichia coli (E. coli) or Klebsiella pneumoniae (K. pneumoniae), according to results of the MERINO* trial.

Tristan Manalac, 19 May 2018
Taking oral antibiotics appears to increase the risk of nephrolithiasis, according to a recent study. Moreover, the risk seems to be compounded for individuals with recent antibiotic exposure and those who were exposed at a younger age.
2 days ago
Patients with inflammatory bowel disease are at increased risk of developing acute myocardial infarction (AMI) or heart failure, although the prevalence of traditional risk factors for such cardiovascular disorders appears to be low, as reported in a recent study.
3 days ago
Early renin-angiotensin-aldosterone system (RAAS) blockade with renin-angiotensin system inhibitors (RASI) leads to better short- and long-term renal outcomes in systemic lupus erythematosus (SLE) patients with antiphospholipid-associated nephropathy (aPLN), according to a study, adding that this renal protective effect is independent of RASI’s antihypertensive and antiproteinuric effects.