Most Read Articles
Elaine Soliven, 4 days ago

Switching from efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) to the new bictegravir/ emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) regimen maintained high rates of virological suppression in adults who are living with HIV*, according to a study presented at AIDS 2020.

2 days ago
Among individuals with abdominal obesity, drinking beverages with artificial sweeteners (ASBs) or no sugar (USBs) instead of sugar-sweetened beverages (SSBs) helps lose body weight, a study has found. However, USBs have a more favourable effect on sweet taste preference compared with ASBs.
Stephen Padilla, 4 days ago
Pre-exposure prophylaxis (PrEP) containing either long-acting injectable cabotegravir (CAB) or tenofovir/emtricitabine (TDF/FTC) is safe and effective for transgender women (TGW) and cisgender men who have sex with men (MSM), but CAB results in a much lower HIV incidence compared to TDF/FTC, results of the HIV Prevention Trials Network (HPTN) 083 have shown.
Jairia Dela Cruz, 3 days ago
Monthly prophylaxis with the fixed-dose combination of naphthoquine-azithromycin (NQAZ) is well tolerated and confers significant protection against infection with Plasmodium parasites among individuals residing in malaria-endemic areas in Southeast Asia, as shown in the results of a phase III trial.

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
Elaine Soliven, 4 days ago

Switching from efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) to the new bictegravir/ emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) regimen maintained high rates of virological suppression in adults who are living with HIV*, according to a study presented at AIDS 2020.

2 days ago
Among individuals with abdominal obesity, drinking beverages with artificial sweeteners (ASBs) or no sugar (USBs) instead of sugar-sweetened beverages (SSBs) helps lose body weight, a study has found. However, USBs have a more favourable effect on sweet taste preference compared with ASBs.
Stephen Padilla, 4 days ago
Pre-exposure prophylaxis (PrEP) containing either long-acting injectable cabotegravir (CAB) or tenofovir/emtricitabine (TDF/FTC) is safe and effective for transgender women (TGW) and cisgender men who have sex with men (MSM), but CAB results in a much lower HIV incidence compared to TDF/FTC, results of the HIV Prevention Trials Network (HPTN) 083 have shown.
Jairia Dela Cruz, 3 days ago
Monthly prophylaxis with the fixed-dose combination of naphthoquine-azithromycin (NQAZ) is well tolerated and confers significant protection against infection with Plasmodium parasites among individuals residing in malaria-endemic areas in Southeast Asia, as shown in the results of a phase III trial.