Contact: Bureau of Cardiology, Allergy, and Neurological Sciences
Summary Basis of Decision (SBD)
Summary Basis of Decision (SBD) documents provide information related to the original authorization of a product. The SBD for Dymista is located below.
Recent Activity for Dymista
SBDs written for eligible drugs approved after September 1, 2012 will be updated to include post-authorization information. This information will be compiled in a Post-Authorization Activity Table (PAAT). The PAAT will include brief summaries of activities such as submissions for new uses of the product, and whether Health Canada's decision was negative or positive. PAATs will be updated regularly with post-authorization activity throughout the product's life cycle. At this time, no PAAT is available for Dymista. When the PAAT for Dymista becomes available, it will be incorporated into this SBD.
Summary Basis of Decision (SBD) for Dymista
Date SBD Issued: 2014/11/27
The following information relates to the original authorization of the new drug submission for Dymista.
On October 23, 2014, Health Canada issued a Notice of Compliance to Meda Pharmaceuticals Ltd. for the drug product, Dymista.
The market authorization was based on quality (chemistry and manufacturing), non-clinical (pharmacology and toxicology), and clinical (pharmacology, safety, and efficacy) information submitted. Based on Health Canada's review, the benefit/risk profile of Dymista is favourable for the symptomatic treatment of moderate to severe seasonal allergic rhinitis (SAR) and associated ocular symptoms in adults and adolescents aged 12 years and older for whom monotherapy with either antihistamines or intranasal corticosteroids is not considered sufficient.
1. What was approved?
Dymista, an antihistamine and corticosteroid, was authorized for the symptomatic treatment of moderate to severe seasonal allergic rhinitis (SAR) and associated ocular symptoms in adults and adolescents aged 12 years and older for whom monotherapy with either antihistamines or intranasal corticosteroids is not considered sufficient.
Dymista is not recommended for use in children
Summary Basis of Decision (SBD)
Summary Basis of Decision (SBD) documents provide information related to the original authorization of a product. The SBD for Dymista is located below.
Recent Activity for Dymista
SBDs written for eligible drugs approved after September 1, 2012 will be updated to include post-authorization information. This information will be compiled in a Post-Authorization Activity Table (PAAT). The PAAT will include brief summaries of activities such as submissions for new uses of the product, and whether Health Canada's decision was negative or positive. PAATs will be updated regularly with post-authorization activity throughout the product's life cycle. At this time, no PAAT is available for Dymista. When the PAAT for Dymista becomes available, it will be incorporated into this SBD.
Summary Basis of Decision (SBD) for Dymista
Date SBD Issued: 2014/11/27
The following information relates to the original authorization of the new drug submission for Dymista.
- Azelastine (as azelastine hydrochloride) and fluticasone propionate
- 137 mcg azelastine hydrochloride and 50 mcg fluticasone propionate per metered spray, suspension for nasal spray, intranasal
- Drug Identification Number (DIN): 02432889
- Meda Pharmaceuticals Ltd.
- New Drug Submission Control Number: 169604
On October 23, 2014, Health Canada issued a Notice of Compliance to Meda Pharmaceuticals Ltd. for the drug product, Dymista.
The market authorization was based on quality (chemistry and manufacturing), non-clinical (pharmacology and toxicology), and clinical (pharmacology, safety, and efficacy) information submitted. Based on Health Canada's review, the benefit/risk profile of Dymista is favourable for the symptomatic treatment of moderate to severe seasonal allergic rhinitis (SAR) and associated ocular symptoms in adults and adolescents aged 12 years and older for whom monotherapy with either antihistamines or intranasal corticosteroids is not considered sufficient.
- What was approved?
- Why was Dymista approved?
- What steps led to the approval of Dymista?
- What follow-up measures will the company take?
- What post-authorization activity has taken place for Dymista?
- What other information is available about drugs?
- What was the scientific rationale for Health Canada's decision?
1. What was approved?
Dymista, an antihistamine and corticosteroid, was authorized for the symptomatic treatment of moderate to severe seasonal allergic rhinitis (SAR) and associated ocular symptoms in adults and adolescents aged 12 years and older for whom monotherapy with either antihistamines or intranasal corticosteroids is not considered sufficient.
Dymista is not recommended for use in children
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