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Original New Drug Application Approvals by US FDA (1 - 15 January 2018)

15 Jan 2018

New drug applications approved by US FDA as of 1-15 January 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.

LEVONORGESTREL; ETHINYL ESTRADIOL; FERROUS

  • Active Ingredient(s): Levonorgesterel; Ethinyl Estradiol; Ferrous
  • Strength: 0.1mg;0.02mg;36.5mg
  • Dosage Form: Tablet; oral
  • Company: Neuvosyn Laboratories LLC
  • Approval Date: January 09, 2018
  • Submission Classification: Not available
  • Indication(s): Indicated for use by females of reproductive potential to prevent pregnancy.
  • Approved Label: 01/09/2018(PDF)
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Most Read Articles
Roshini Claire Anthony, 02 Feb 2018

The use of weight loss medications for at least 1 year did little to improve cardiometabolic risk factors in obese adults, according to a systematic review and meta-analysis.

17 Feb 2019
In patients with type 2 diabetes (T2D), sodium-glucose cotransporter 2 (SGLT2) inhibitor monotherapy, particularly canagliflozin, exerts greater effects on weight compared with metformin and dipeptidyl peptidase 4 (DPP-4) inhibitors or gliptins, according to the results of a meta-analysis.
26 Feb 2019
Oral fluoxetine confers beneficial effects in the management of adult and adolescent amblyopia, suggests a recent study.
19 Feb 2019
Preprandial administration of metformin successfully and safely reduces postprandial plasma triglyceride levels, a new study has shown.