Most Read Articles
05 Aug 2015
The five A’s algorithm for quitting tobacco use is to ask, advise, assess, assist and arrange, while the five R’s stand for relevance, risks, rewards, roadblocks and repetition, says a specialist.
05 Jan 2018
At a recent dinner symposium at Shangri-La Kuala Lumpur, Dr Omar Usmani discussed the importance of inhaler devices in the management of asthma and chronic obstructive pulmonary disease (COPD).
27 Dec 2017
The prevalence of allergic diseases in the Asia-Pacific region is expected to rise over the next 20 years, driven by rapid economic development and urbanization. Allergic diseases have high socioeconomic impact by impairing productivity and quality of life, and the impact may be greater in Asia-Pacific than in Europe due to the presence and predominance of perennial allergens.
Pearl Toh, 27 Dec 2017
The presence of eczema or atopic dermatitis with concurrent allergic sensitization at 1 year of age was associated with an increased risk of developing asthma and food allergy in later childhood at 3 years old, according to the CHILD* study.

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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Editor's Recommendations
Most Read Articles
05 Aug 2015
The five A’s algorithm for quitting tobacco use is to ask, advise, assess, assist and arrange, while the five R’s stand for relevance, risks, rewards, roadblocks and repetition, says a specialist.
05 Jan 2018
At a recent dinner symposium at Shangri-La Kuala Lumpur, Dr Omar Usmani discussed the importance of inhaler devices in the management of asthma and chronic obstructive pulmonary disease (COPD).
27 Dec 2017
The prevalence of allergic diseases in the Asia-Pacific region is expected to rise over the next 20 years, driven by rapid economic development and urbanization. Allergic diseases have high socioeconomic impact by impairing productivity and quality of life, and the impact may be greater in Asia-Pacific than in Europe due to the presence and predominance of perennial allergens.
Pearl Toh, 27 Dec 2017
The presence of eczema or atopic dermatitis with concurrent allergic sensitization at 1 year of age was associated with an increased risk of developing asthma and food allergy in later childhood at 3 years old, according to the CHILD* study.