Most Read Articles
21 Mar 2018
During the Kuala Lumpur International Neonatology Conference held in conjunction with the World Prematurity Day 2017, Dato Dr Musa Mohd Nordin spoke on the importance of immunizing children with the diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae type b (DTaP-IPV-Hib) vaccine. He highlighted the role of Hexaxim® as a fully liquid, ready-to-use, 6-in-1 (including hepatitis B) vaccine for the primary and booster vaccinations of infants and toddlers. Meanwhile, Dr Yong Junina Fadzil discussed the benefits of quadrivalent influenza vaccines (QIVs) in providing children with broader protection against influenza B viruses.
Kavitha G. Shekar, 19 Aug 2015
Haematologic disorder, increasing age, malar rash, and autoantibodies are early predictors of arthritis in paediatric patients with systemic lupus erythematosus (SLE), a longitudinal cohort study has shown.
01 Dec 2017
Bifidobacteria supplementation to infant diet helps curb the occurrence of specific bacteria and metabolites during early life, a recent study has shown, adding that no long-term effects have been detected.

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
21 Mar 2018
During the Kuala Lumpur International Neonatology Conference held in conjunction with the World Prematurity Day 2017, Dato Dr Musa Mohd Nordin spoke on the importance of immunizing children with the diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae type b (DTaP-IPV-Hib) vaccine. He highlighted the role of Hexaxim® as a fully liquid, ready-to-use, 6-in-1 (including hepatitis B) vaccine for the primary and booster vaccinations of infants and toddlers. Meanwhile, Dr Yong Junina Fadzil discussed the benefits of quadrivalent influenza vaccines (QIVs) in providing children with broader protection against influenza B viruses.
Kavitha G. Shekar, 19 Aug 2015
Haematologic disorder, increasing age, malar rash, and autoantibodies are early predictors of arthritis in paediatric patients with systemic lupus erythematosus (SLE), a longitudinal cohort study has shown.
01 Dec 2017
Bifidobacteria supplementation to infant diet helps curb the occurrence of specific bacteria and metabolites during early life, a recent study has shown, adding that no long-term effects have been detected.