Most Read Articles
Roshini Claire Anthony, 19 Jan 2018

The combination of ceftazidime and avibactam proved noninferior to meropenem in adults with nosocomial pneumonia, positioning it as a potential treatment option for this condition, results from the phase III REPROVE* trial show. Nonetheless, the combination was associated with a higher number of safety events compared with meropenem.

01 Jun 2016
Fluticasone furoate is superior to mometasone nasal spray in improving several perceived sensory attributes of allergic rhinitis patients, based on a multicentre, randomised, crossover, prospective study.
01 Aug 2014
Bilastine demonstrated high efficacy in the treatment of patients with allergic rhinitis, based on an analysis of publications.
15 Aug 2017
New drug applications approved by US FDA as of 1 - 15 August 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.

Original New Drug Application Approvals by US FDA (15-30 Aug)

16 Aug 2014

As of 30 Aug 2014

Below are all applications approved for the first time during the selected month by US FDA. It includes New Molecular Entities (NMEs) and new biologics. It does not include Tentative Approvals. Supplemental approvals may have occurred since the original approval date.

BASAGLAR  

  • Active Ingredient(s): Insulin Glargine
  • Strength: TBD   
  • Dosage Form: Injection    
  • Company: ELI LILLY AND CO
  • Approval Date: August 18, 2014
  • Chemical Type: 5  New formulation or new manufacturer
  • Indication(S): Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
  • Approved Label: not available

 
CERDELGA

  • Active Ingredient(s): Eliglustat
  • Strength: 84 mg
  • Dosage Form: Capsules, oral
  • Company: GENZYME CORP
  • Approval Date: August 19, 2014
  • Chemical Type: 1  New molecular entity (NME)
  • Indication(S): Indicated for the long-term treatment of adult patients with Gaucher disease type 1 who are CYP2D6 extensive metabolizers(EMs) , intermediate metabolizers (IMs), or poor metabolizers (PMs) as detected by an FDA- cleared test.
  • Approved Label: 08/19/2014 (PDF)

ARNUITY ELLIPTA  

  • Active Ingredient(s): Fluticasone Furoate
  • Strength: 100µg ; 200µg    
  • Dosage Form: Inhalation Powder   
  • Company: GLAXOSMITHKLINE  
  • Approval Date: August 20, 2014
  • Chemical Type: 5  New formulation or new manufacturer
  • Indication(S): Once daily maintenance treatment of asthma as prophylactic therapy in patients aged 12 years and older.
  • Approved Label: 08/20/2014 (PDF)

  
TRIUMEQ  

  • Active Ingredient(s): Abacavir; Dolutegravir; Lamivudine
  • Strength: 600 mg/50 mg/300 mg
  • Dosage Form: Tablets; Oral  
  • Company: VIIV HLTHCARE
  • Approval Date: August 22, 2014
  • Chemical Type: 4 New combination
  • Indication(S):Indicated for the treatment of HIV-1 infection.
  • Approved Label: 08/22/2014 (PDF)

KABIVEN AND PERIKABIVEN  

  • Active Ingredient(s): Amino acids, Electrolytes, Dextrose , Lipid
  • Strength: 19 to 38 mL/kg/day; 27 to 40 mL/kg/day     
  • Dosage Form: Injectable Emulsion
  • Company: FRESENIUS KABI  
  • Approval Date: August 25, 2014
  • Chemical Type: 1 New molecular entity (NME)
  • Indication(S): Indicated for adult patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated; Used to prevent essential fatty acid deficiency or treat negative nitrogen balance in adult patients.
  • Approved Label: 08/25/2014 (PDF)

 

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Most Read Articles
Roshini Claire Anthony, 19 Jan 2018

The combination of ceftazidime and avibactam proved noninferior to meropenem in adults with nosocomial pneumonia, positioning it as a potential treatment option for this condition, results from the phase III REPROVE* trial show. Nonetheless, the combination was associated with a higher number of safety events compared with meropenem.

01 Jun 2016
Fluticasone furoate is superior to mometasone nasal spray in improving several perceived sensory attributes of allergic rhinitis patients, based on a multicentre, randomised, crossover, prospective study.
01 Aug 2014
Bilastine demonstrated high efficacy in the treatment of patients with allergic rhinitis, based on an analysis of publications.
15 Aug 2017
New drug applications approved by US FDA as of 1 - 15 August 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.