Most Read Articles
Stephen Padilla, 4 days ago
Treatment with oral thrombopoietin receptor agonist eltrombopag leads to similar platelet counts in patients with chronic immune thrombocytopaenia (cITP) and persistent (per)ITP, according to the results of phase III (EXTEND) and IV studies presented at the 23rd Congress of the European Hematology Association (EHA 2018) held in Stockholm, Sweden.
4 days ago
Socioeconomic status, along with other social determinants, appears to influence the long-term outcomes in Asian acute heart failure patients, according to a recent Japan study.
Pearl Toh, 6 days ago
Lonely people were twice as likely to die from any cause than people who did not feel lonely, according to a study based on a national survey presented at the recent EuroHeartCare 2018 in Dublin, Ireland. Also, loneliness is associated with poorer patient-reported outcomes in terms of mental and physical health in patients with heart disease.
Jairia Dela Cruz, 4 days ago
A treatment regimen combining daratumumab plus bortezomib, melphalan and prednisone markedly extends progression-free survival in patients with multiple myeloma, inducing deep responses and demonstrating acceptable tolerability regardless of baseline renal function, according to the results of the phase III ALCYONE study.

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

16 Feb 2018

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

EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL

  • Active Ingredient(s): Efavirenz; Lamivudine; Tenofovir Disoproxil
  • Strength: 400 mg; 300 mg; 245 mg
  • Dosage Form: Tablet; Oral
  • Company: Mylan Pharms Inc
  • Approval Date: February 5, 2018
  • Submission Classification: Type 3 - New Dosage Form
  • 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 35 kg
  • Approved Label: 02/05/2018 (PDF)

BIKTARVY
  • Active Ingredient(s): Bictegravir; Emtricitabine; Tenofovir Alafenamide
  • Strength: 50 mg; 200 mg; 25 mg
  • Dosage Form: Tablet; Oral
  • Company: Gilead Sciences Inc
  • Approval Date:February 7, 2018
  • Submission Classification: Type 1 - New Molecular Entity and Type 4 - New Combination
  • Indication(s): Indicated as a complete regimen for the treatment of HIV-1 infection in adults who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen for at least 3 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of BIKTARVY
  • Approved Label: 02/07/2018 (PDF)

RADIOGENIX SYSTEM
  • Active Ingredient(s): Sodium Pertechnetate
  • Strength: 6 Cl
  • Dosage Form: Injectable; Injection
  • Company: Northstar Medical Radioisotopes LLC
  • Approval Date: February 8, 2018
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated as a radioactive diagnostic agent and can be used in the preparation of FDA approved diagnostic radiopharmaceuticals.  Also indicated in adults for Salivary Gland Imaging and Nasolacrimal Drainage System Imaging (dacryoscintigraphy) and in adults and pediatric patients for Thyroid Imaging and Vesicoureteral Imaging (direct isotopic cystography) for detection of vesicoureteral reflux.
  • Approved Label02/08/2018 (PDF)

DEXYCU
  • Active Ingredient(s): Dexamethasone
  • Strength: 9%
  • Dosage Form: Suspension; Intraocular
  • Company: Icon Bioscience Inc
  • Approval Date: February 9, 2018
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for the treatment of postoperative inflammation
  • Approved Label02/09/2018 (PDF)

SYMDEKO
  • Active Ingredient(s): Tezacaftor; Ivacaftor
  • Strength: 100; 150 mg
  • Dosage Form: Tablet; Oral
  • Company: Vertex Pharms
  • Approval Date: February 12, 2018
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of patients with cystic fibrosis (CF) aged 12 years and older who are homozygous for the F508del mutation or who have at least one mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to tezacaftor/ivacaftor based on in vitro data and/or clinical evidence
  • Approved Label02/12/2018 (PDF)

ERLEADA
  • Active Ingredient(s): Apalutamide
  • Strength: 60 mg
  • Dosage Form: Tablet; Oral
  • Company: Janssen Biotech
  • Approval Date: February 14, 2018
  • Submission Classification: Not available
  • Indication(s): Indicated for the treatment of patients with non-metastatic castration-resistant prostate cancer
  • Approved Label: 02/14/2018 (PDF)
Digital Edition
Asia's trusted medical magazine for healthcare professionals. Get your MIMS Doctor - Malaysia digital copy today!
Sign In To Download
Editor's Recommendations
Most Read Articles
Stephen Padilla, 4 days ago
Treatment with oral thrombopoietin receptor agonist eltrombopag leads to similar platelet counts in patients with chronic immune thrombocytopaenia (cITP) and persistent (per)ITP, according to the results of phase III (EXTEND) and IV studies presented at the 23rd Congress of the European Hematology Association (EHA 2018) held in Stockholm, Sweden.
4 days ago
Socioeconomic status, along with other social determinants, appears to influence the long-term outcomes in Asian acute heart failure patients, according to a recent Japan study.
Pearl Toh, 6 days ago
Lonely people were twice as likely to die from any cause than people who did not feel lonely, according to a study based on a national survey presented at the recent EuroHeartCare 2018 in Dublin, Ireland. Also, loneliness is associated with poorer patient-reported outcomes in terms of mental and physical health in patients with heart disease.
Jairia Dela Cruz, 4 days ago
A treatment regimen combining daratumumab plus bortezomib, melphalan and prednisone markedly extends progression-free survival in patients with multiple myeloma, inducing deep responses and demonstrating acceptable tolerability regardless of baseline renal function, according to the results of the phase III ALCYONE study.