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Roshini Claire Anthony, Yesterday

Patients undergoing chemotherapy for breast or haematological cancers could potentially reduce their risk of chemotherapy-related cardiotoxicity with the use of angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor antagonists (ARBs), or beta-blockers as primary prevention, according to a systematic review and meta-analysis presented at the recent EuroEcho 2019 conference.

29 Nov 2019
Metformin Extended Release 500 mg,750 mg, and 1000 mg
6 days ago
Men who undergo flexible cystoscopy, particularly with a longer dwell time, may benefit from intraurethral lidocaine as it provides significant pain reduction, suggest the results of a meta-analysis. Evidence is lacking for other tested interventions.
Tristan Manalac, 2 days ago
Users of electronic nicotine delivery systems are likely to have received a diagnosis of clinical depression in the past, according to a recent study.

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
Roshini Claire Anthony, Yesterday

Patients undergoing chemotherapy for breast or haematological cancers could potentially reduce their risk of chemotherapy-related cardiotoxicity with the use of angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor antagonists (ARBs), or beta-blockers as primary prevention, according to a systematic review and meta-analysis presented at the recent EuroEcho 2019 conference.

29 Nov 2019
Metformin Extended Release 500 mg,750 mg, and 1000 mg
6 days ago
Men who undergo flexible cystoscopy, particularly with a longer dwell time, may benefit from intraurethral lidocaine as it provides significant pain reduction, suggest the results of a meta-analysis. Evidence is lacking for other tested interventions.
Tristan Manalac, 2 days ago
Users of electronic nicotine delivery systems are likely to have received a diagnosis of clinical depression in the past, according to a recent study.