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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
Tristan Manalac, 5 days ago
Atopic dermatitis appears to impair sleep quality, but not sleep duration, in children, particularly in those with more severe diseases, according to a new study.
6 days ago
Individuals following a diet low in or free of meat are at lower risk of diabetes, and this protective association is partly attributable to having a lower body mass index when compared with regular meat eaters, according to a study.
3 days ago
Drinking coffee confers benefits for recurrence of hepatocellular carcinoma (HCC) and survival following orthotopic liver transplantation, a study has found.
6 days ago
Vitamin E supplementation does not appear to contribute to blood pressure (BP) improvement, with results of a recent systematic review and meta-analysis showing decreases only in systolic (S)BP but no favourable effect on diastolic (D)BP and mean arterial pressure (MAP).