Most Read Articles
Roshini Claire Anthony, 4 days ago

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.

Tristan Manalac, 5 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.
Pearl Toh, 06 Dec 2019
Getting just under one extra hour of sleep per night can go a long way for the health of college students, who are often sleep-deprived, a study suggests.
Jairia Dela Cruz, 3 days ago
Use of isatuximab (Isa) in combination with pomalidomide and dexamethasone (PomDex) appears to lead to more favourable outcomes in elderly patients with relapsed/refractory multiple myeloma (RRMM) as compared with PomDex alone, according to the results of a subgroup analysis of the ICARIA-MM trial presented at the 61st Annual Meeting of the American Society of Hematology (ASH 2019).

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, 4 days ago

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.

Tristan Manalac, 5 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.
Pearl Toh, 06 Dec 2019
Getting just under one extra hour of sleep per night can go a long way for the health of college students, who are often sleep-deprived, a study suggests.
Jairia Dela Cruz, 3 days ago
Use of isatuximab (Isa) in combination with pomalidomide and dexamethasone (PomDex) appears to lead to more favourable outcomes in elderly patients with relapsed/refractory multiple myeloma (RRMM) as compared with PomDex alone, according to the results of a subgroup analysis of the ICARIA-MM trial presented at the 61st Annual Meeting of the American Society of Hematology (ASH 2019).