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Original New Drug Application Approvals by US FDA (16 - 31 October 2017)

31 Oct 2017
New drug applications approved by US FDA as of 16 - 31 October 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.

BYDUREON BCISE (exenatide extended-release) injectable suspension
  • Active Ingredient(s): Exenatide
  • Strength: 2 mg
  • Dosage Form: Intramuscular extended release suspension
  • Company:  Astrazeneca AB
  • Approval Date: October 20, 2017
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
  • Approved Label: 10/20/2017 (PDF)

DAPTOMYCIN
  • Active Ingredient(s): Daptomycin
  • Strength: 350 mg/vial
  • Dosage Form: Injectable; Injection
  • Company: Xellia Pharms APS
  • Approval Date: October 20,2017
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for the treatment of: 
    • Complicated skin and skin structure infections (cSSSI) in adult patients
    • Staphylococcus aureus bloodstream infections (bacteremia), including those with right-sided infective endocarditis in adult patients
  • Approved Label: 10/20/2017 (PDF)

CARBON DIOXIDE
  • Active Ingredient(s): Carbon Dioxide
  • Strength: Unknown
  • Dosage Form: Gas; Inhalation
  • Company: Liss America LLC
  • Approval Date: October 20, 2017
  • Submission Classification: Not Applicable
  • Indication(s): Not Applicable
  • Approved Label: Not Applicable

VARUBI
  • Active Ingredient(s): Rolapitant
  • Strength: 166.5 mg/92.5 ml (1.8 mg/ml)
  • Dosage Form: Injectable; Injection
  • Company: Tesaro Inc
  • Approval Date: October 25, 2017
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated in combination with other antiemetic agents in adults for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy
  • Approved Label: 10/25/2017 (PDF)

PREXXARTAN
  • Active Ingredient(s): Valsartan
  • Strength: 4mg/mL
  • Dosage Form: Oral Solution
  • Company: Carmel Biosciences Inc
  • Approval Date: October 30, 2017
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for:
    • Treatment of hypertension in adults and children six years and older, to lower blood pressure
    • Treatment of heart failure (NYHA class II-IV) to reduce the risk of hospitalization for heart failure in patients who are unable to swallow valsartan tablets
    • To reduce the risk of cardiovascular death in clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction who are unable to swallow valsartan tablets
  • Approved Label: Not available

CALQUENCE
  • Active Ingredient(s): Acalabrutinib
  • Strength: 100 mg
  • Dosage Form: Oral capsule
  • Company: Acerta Pharma BV
  • Approval Date: October 31, 2017
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy
  • Approved Label: 10/31/2017 (PDF)
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Most Read Articles
5 days ago
In patients with type 2 diabetes, obesity may be protective against vision-threatening diabetic retinopathy, a recent Korea study has shown.
Roshini Claire Anthony, 4 days ago

Men with metastatic hormone-sensitive prostate cancer (mHSPC) who receive testosterone suppression therapy may have a better survival outcome with the addition of enzalutamide over other non-steroidal anti-androgen (NSAA) therapies, according to the phase III ENZAMET* trial.

07 Jun 2019
Low-dose aspirin therapy does not confer significant benefits to elderly patients with hypertension, but treatment appears to increase the risk of haemorrhagic events, suggest a Japan study.
4 days ago
The use of opioids may have limited long-term efficacy in the management of chronic noncancer pain, reports a new study.