Phase 3 Results for Dymista for Allergic Rhinitis
Meda announced new results from its Phase 3 study of Dymista (azelastine HCl and fluticasone propionate; Meda) nasal spray for the treatment of allergic rhinitis.
Allergic Disorders
NDA Accepted for Dymista for Allergic Rhinitis
The FDA has accepted for filing the NDA for Dymista (azelastine HCl and fluticasone propionate; Meda) nasal spray for the treatment of allergic rhinitis.
Arbinoxa Tablets and Oral Solution Available for Allergies
Hawthorn Pharmaceuticals announced that Arbinoxa (carbinoxamine) tablets and oral solution are available for the treatment of allergic (seasonal and perennial) and vasomotor rhinitis, conjunctivitis, urticaria, angioedema, and reactions to blood.
Phase 3 Study of Dymista for Seasonal Allergic Rhinitis
Meda announced positive results from its Phase 3 trial of Dymista (azelastine HCl and fluticasone propionate) nasal spray in patients with seasonal allergic rhinitis
American Regent Recalls Sodium Chloride and Dexamethasone Injections
American Regent announced a voluntary nationwide recall of concentrated sodium chloride injection, bacteriostatic sodium chloride injection, and dexamethasone sodium phosphate injection.
Phase 3b study of RHUCIN for the treatment of acute hereditary angioedema
Santarus and Pharming announced initiation of their Phase 3b study of RHUCIN (recombinant human C1 inhibitor) for the treatment of acute attacks of angioedema in patients with hereditary angioedema.
FDA reminder of safe non-sterile alcohol prep pad use
The FDA is reminding healthcare professionals about the safe use of non-sterile alcohol prep pads to clean and disinfect the surface of the skin.
Allegra and Allegra-D Approved for Over-The-Counter Use
The FDA has approved sanofi-aventis’ Allegra and Children’s Allegra (fexofenadine) and Allegra-D (fexofenadine and pseudoephedrine) product lines to be marketed over-the-counter.
Phase 3 study of Firazyr for the treatment of hereditary angioedema (HAE)
Shire announced topline results from FAST-3, the largest of its Phase 3 trials studying the use of Firazyr (icatibant) for treatment of acute attacks of hereditary angioedema (HAE).
