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Original New Drug Application Approvals by US FDA (16 - 30 April 2018)

30 Apr 2018

New drug applications approved by US FDA as of 16 - 30 April 2018 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.

TAVALISSE

  • Active Ingredient(s): Fostamatinib
  • Strength: 100MG; 150MG
  • Dosage Form: Tablet
  • Company: Rigel Pharms Inc
  • Approval Date: 17 April 2018
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment
  • Approved Label17/04/2018 (PDF)

CRYSVITA
  • Active Ingredient(s): Burosumab-twza
  • Strength: 10MG/ML
  • Dosage Form: Injectable
  • Company: Ultragenyx Pharm Inc
  • Approval Date: 17 April 2018
  • Submission Classification: Not available
  • Indication(s): Indicated for the treatment of X-linked hypophosphatemia (XLH) in adult and pediatric patients 1 year of age and older
  • Approved Label17/04/2018 (PDF)

AKYNZEO
  • Active Ingredient(s): Fosnetupitant; Palonosetron hydrochloride
  • Strength: 235MG; 0.25MG
  • Dosage Form: Injectable
  • Company: Helsinn Healthcare
  • Approval Date: 19 April 2018
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy
  • Approved Label19/04/2018 (PDF)

JYNARQUE
  • Active Ingredient(s): Tolvaptan
  • Strength: 15MG; 30MG; 45MG; 60MG; 90MG
  • Dosage Form: Tablet, chewable tablet, capsule
  • Company: Otsuka Pharm Co Ltd
  • Approval Date: 23 April 2018
  • Submission Classification: Type 10 - New Indication Submitted as Distinct NDA - Not Consolidated
  • Indication(s): Not available
  • Approved Label: Not available

HYDROCODONE BITARTRATE; GUAIFENESIN
  • Active Ingredient(s): Hydrocodone bitartrate; Guaifenesin
  • Strength: 5MG; 400MG
  • Dosage Form: Tablet
  • Company: ECI Pharms LLC
  • Approval Date: 25 April 2018
  • Submission Classification: Type 3 - New Dosage Form and Type 4 - New Combination
  • Indication(s): Indicated for the symptomatic relief of cough and to loosen mucus associated with the common cold in patients 18 years of age and older
  • Approved Label25/04/2018 (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.
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