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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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Editor's Recommendations
Most Read Articles
2 days ago
Podcast: Dr Shamir Mehta briefly discusses the clinical impact of findings from the COMPLETE trial
2 days ago
Podcast: Prof Derek Chew explains the importance of a 1-hour troponin T protocol in suspected ACS as discussed in the RAPID-TnT trial
2 days ago
Sodium-glucose transport protein 2 (SGLT2) inhibitors exert a putative epigenetic regulation of the protecting cardiovascular effect, reports a study, adding that dapagliflozin may protect the kidneys by preserving renal vasodilating capacity.
Pank Jit Sin, 5 days ago

The Malaysian Endocrine and Metabolic Society (MEMS) and Malaysian Diabetes Educators Society (MDES) jointly launched the For Your Sweetheart campaign—a nationwide endeavour to increase public awareness and to educate Malaysians about diabetes-related heart disease.