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Original New Drug Application Approvals by US FDA (16 - 31 March 2018)

31 Mar 2018

New drug applications approved by US FDA as of 16-31 March 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.

ILUMYA

  • Active Ingredient(s): Tildrakizumab-A SMN
  • Strength: 100 mg/1 ml
  • Dosage Form: Injectable;injection
  • Company: Merck Sharp Dohme
  • Approval Date: March 20, 2018
  • Submission Classification: Not applicable
  • Indication(s): Not applicable
  • Approved Label: Not applicable

SYMFI
  • Active Ingredient(s): Efavirenz; Lamivudine; Tenofovir Disoproxil Fumarate
  • Strength: 600 mg; 300mg; 300 mg
  • Dosage Form: Tablet; Oral
  • Company: Matrix Labs LTD
  • Approval Date: March 22, 2018
  • Submission Classification: Type 4 - New Combination
  • Indication(s): Indicated  as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult and pediatric patients weighing at least 40 kg.
  • Approved Label: 03/22/2018(PDF)

PEMETREXED
  • Active Ingredient(s): Pemetrexed
  • Strength: 100 mg; 500 mg
  • Dosage Form: Inejctable;injection
  • Company: Apotex Inc
  • Approval Date: March 28, 2018
  • Submission Classification: Type 2 - New Active Ingredient
  • Indication(s): Not applicable
  • Approved Label: Not applicable
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