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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
Pearl Toh, 31 Dec 2019
Adding the neuraminidase inhibitor oseltamivir to usual care speeds up recovery from influenza-like illness by a day compared with usual care alone, with even greater benefits seen in older, sicker patients with comorbidities, according to the ALIC4E study.
09 Jan 2020
Acute ischaemic stroke patients who are current or recent smokers are at greater odds of having unfavourable functional outcomes 3 months after the index event, a study has found.
Stephen Padilla, 2 days ago
Brodalumab has exhibited long-term efficacy and consistent safety profile for more than 2 years in the treatment of patients with psoriasis, results of the phase III AMAGINE-2 trial show.
2 days ago
Anaemia increases mortality risk in heart failure (HF) patients across the ejection fraction (EF) spectrum, a recent study has found. The effect appears to be stronger in preserved (HFpEF) and midrange (HFmrEF) than in reduced (HFrEF) EF disease.