Most Read Articles
Elaine Soliven, 17 Aug 2017
Probiotic supplementation during the first 6 months of life does not reduce the incidence of eczema or asthma later in childhood, according to the randomized controlled TIPS* study.

Original New Drug Application Approvals by US FDA (16 - 31 July 2017)

31 Jul 2017
New drug applications approved by US FDA as of 16 - 31 July 2017 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.

NERLYNX
  • Active Ingredient(s): NERATINIB MALEATE
  • Strength: 40MG
  • Dosage Form: Oral Tablet
  • Company: Puma Biotech Inc
  • Approval Date: July 17, 2017
  • Chemical Type: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, to follow adjuvant trastuzumab-based therapy
  • Approved Label: 07/17/2017 (PDF)

VOSEVI
  • Active Ingredient(s): SOFOSBUVIR;VELPATASVIR;VOXILAPREVIR
  • Strength: 400MG;100MG;100MG
  • Dosage Form: Oral Tablet
  • Company: Gilead Sciences Inc
  • Approval Date: July 18, 2017
  • Chemical Type: Type 1 - New Molecular Entity and Type 4 - New Combination
  • Indication(s): Indicated for the treatment of adult patients with chronic HCV infection without cirrhosis or with compensated cirrhosis (Child-Pugh A) who have (1, 2.2, 14):
    • genotype 1, 2, 3, 4, 5, or 6 infection and have previously been treated with an HCV regimen containing an NS5A inhibitor
    • genotype 1a or 3 infection and have previously been treated with an HCV regimen containing sofosbuvir without an NS5A inhibitor: Additional benefit of VOSEVI over sofosbuvir/velpatasvir was not shown in adults with genotype 1b, 2, 4, 5, or 6 infection previously treated with sofosbuvir without an NS5A inhibitor
  • Approved Label: 07/18/2017 (PDF)

LUSDUNA
  • Active Ingredient(s): INSULIN GLARGINE
  • Strength: 100UNITS/ML
  • Dosage Form: Injectable; Injection
  • Company: Merck Sharp Dohme
  • Approval Date: July 19, 2017
  • Chemical Type: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus
  • Approved Label: Not available

BENLYSTA
  • Active Ingredient(s): BELIMUMAB
  • Strength: 200MG/ML
  • Dosage Form: Injectable;Injection
  • Company: Glaxosmithkline LLC
  • Approval Date: July 20, 2017
  • Chemical Type: Not available
  • Indication(s): Indicated for the treatment of adult patients with active, autoantibody-positive, systemiclupus erythematosus who are receiving standard therapy
  • Approved Label: 07/20/2017 (PDF)

NITYR
  • Active Ingredient(s): NITISINONE
  • Strength: 2MG, 5MG, 10MG
  • Dosage Form: Oral Tablet
  • Company: Cycle Pharms LTD
  • Approval Date: July 26, 2017
  • Chemical Type: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for the treatment of hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine
  • Approved Label: 07/26/2017 (PDF)

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Most Read Articles
Elaine Soliven, 17 Aug 2017
Probiotic supplementation during the first 6 months of life does not reduce the incidence of eczema or asthma later in childhood, according to the randomized controlled TIPS* study.