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07 Aug 2020
Concomitant treatment with a nonsteroidal anti-inflammatory drug (NSAID) following myocardial infarction (MI) is associated with a higher risk of cardiovascular and bleeding events, a study has shown.
Roshini Claire Anthony, 06 Oct 2020

Several strategies have been proposed to help manage the adverse events (AEs) that emerged during the BEACON CRC trial which assessed the effect of encorafenib plus cetuximab in patients with BRAF V600E mutant metastatic colorectal cancer (mCRC) who had progressed after one or two prior regimens.

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
07 Aug 2020
Concomitant treatment with a nonsteroidal anti-inflammatory drug (NSAID) following myocardial infarction (MI) is associated with a higher risk of cardiovascular and bleeding events, a study has shown.
Roshini Claire Anthony, 06 Oct 2020

Several strategies have been proposed to help manage the adverse events (AEs) that emerged during the BEACON CRC trial which assessed the effect of encorafenib plus cetuximab in patients with BRAF V600E mutant metastatic colorectal cancer (mCRC) who had progressed after one or two prior regimens.