Most Read Articles
28 Nov 2019
The occurrence and severity of hidradenitis suppurativa (HS) are associated with micronutrient status and obesity, suggesting that weight loss and dietary modifications should be considered in the treatment of HS patients, according to the results of a systematic review and meta-analysis.
10 Dec 2019
Oral H1-antihistamines are the initial treatment of choice for allergic rhinitis (AR) and chronic urticaria in the primary care setting. However, in a diverse population of patients with AR and urticaria, primary care physicians are faced with the challenge of prescribing the best therapy amid a wide armamentarium of antihistamines available.
27 Nov 2019
Earlier-onset atopic dermatitis in children appears to correlate with stronger persistence over time and worse disease control, a recent study has found.

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
Editor's Recommendations
Most Read Articles
28 Nov 2019
The occurrence and severity of hidradenitis suppurativa (HS) are associated with micronutrient status and obesity, suggesting that weight loss and dietary modifications should be considered in the treatment of HS patients, according to the results of a systematic review and meta-analysis.
10 Dec 2019
Oral H1-antihistamines are the initial treatment of choice for allergic rhinitis (AR) and chronic urticaria in the primary care setting. However, in a diverse population of patients with AR and urticaria, primary care physicians are faced with the challenge of prescribing the best therapy amid a wide armamentarium of antihistamines available.
27 Nov 2019
Earlier-onset atopic dermatitis in children appears to correlate with stronger persistence over time and worse disease control, a recent study has found.