Meda Pharmaceuticals in Canada has announced that Health Canada has approved Dymista azelastine hydrochloride/fluticasone propionate nasal spray for the treatment of moderate-to-severe seasonal allergic rhinitis for patients age 12 years old and older who do not achieve sufficient symptom relief with either antihistamines or intranasal corticosteroids. According … [Read more...] about Meda announces launch of Dymista nasal spray in Canada
Regulatory
FDA grants priority review to Adapt Pharma’s NDA for Narcan naloxone nasal spray
Adapt Pharma announced that the FDA has accepted its filing and granted priority review to its New Drug Application for Narcan naloxone hydrochloride nasal spray for the treatment of opioid overdose. Adapt submitted the NDA in July 2015. Lightlake Therapeutics licensed the nasal spray to Adapt in December 2014, and the FDA granted Fast Track designation for the … [Read more...] about FDA grants priority review to Adapt Pharma’s NDA for Narcan naloxone nasal spray
GSK and Theravance announce planned submission of Japanese sNDA for Relvar Ellipta
GlaxoSmithKline and Theravance have announced plans to file a supplemental Japanese New Drug Application for the Relvar/Breo Ellipta fluticasone furoate/vilanterol DPI for the treatment of COPD in the first quarter of 2016. The Japanese MHLW approved Relvar Ellipta for the treatment of asthma in patients 15 years old and older in September 2013. The companies also … [Read more...] about GSK and Theravance announce planned submission of Japanese sNDA for Relvar Ellipta
FDA approves Spiriva Respimat for the treatment of asthma
Boehringer Ingelheim's Spiriva Respimat tiotropium soft mist inhaler has now been approved by the FDA for the treatment of asthma in patients 12 years old and older. Spiriva Respimat was approved for the treatment of COPD in the US in September 2014, and it is currently approved for the treatment of asthma in over 50 countries. Boehringer Ingelheim Head of … [Read more...] about FDA approves Spiriva Respimat for the treatment of asthma
FDA accepts Teva’s sNDA for ProAir Respiclick for pediatric use
Teva has announced the FDA's acceptance of a supplemental new drug application (sNDA) for the ProAir RespiClick albuterol DPI for the treatment of asthma in patients aged 4 to 11. The FDA approved ProAir RespiClick for the treatment of asthma in patients 12 and older in March 2015. Teva Senior VP, Teva Global Respiratory R&D, Tushar Shah commented, “The acceptance … [Read more...] about FDA accepts Teva’s sNDA for ProAir Respiclick for pediatric use
Serendex to begin Phase 2 trial of inhaled molgramostim
According to Serendex Pharmaceuticals, German regulators have cleared the way for the company to initiate a phase 2 clinical trial of inhaled molgramostim (Molgradex) for the treatment of pneumonia-associated acute respiratory distress syndrome (ARDS). Earlier this year, the company announced that it had partnered with the Universities of Giessen and Marburg Lung … [Read more...] about Serendex to begin Phase 2 trial of inhaled molgramostim
Breo Ellipta approved for the treatment of asthma in Canada
GSK and Theravance, Inc. have announced that the Breo Ellipta fluticasone furoate/vilanterol DPI has been approved in Canada in 100/25 mcg and 200/25 mcg versions for the treatment of asthma in patients aged 18 years and older. Breo Ellipta was approved in Canada for the treatment of COPD in July 2013. Theravance, Inc. President and CEO Michael W. Aguiar … [Read more...] about Breo Ellipta approved for the treatment of asthma in Canada
FDA approval for Breckenridge’s azelastine nasal spray
Florida-based Breckenridge Pharmaceutical has announced the launch of its azelastine HCl nasal spray, a generic version of Meda's Astelin, after receiving final FDA approval of its ANDA. The product is approved for the treatment of seasonal allergic rhinitis in patients aged 5 years and older for the treatment of vasomotor rhinitis in patients 12 years and … [Read more...] about FDA approval for Breckenridge’s azelastine nasal spray
Allergan confirms submission of ANDA for treprostinil inhalation solution
Allergan has confirmed that it submitted an Abbreviated New Drug Application (ANDA) with the FDA for a generic version of United Therapeutics' Tyvaso treprostinil inhalation solution for the treatment of pulmonary arterial hypertension and says it believes that it is the first applicant to file. In June 2015, United Therapeutics announced that it had received … [Read more...] about Allergan confirms submission of ANDA for treprostinil inhalation solution
Indivior announces submission of NDA for naloxone nasal spray
Two days after Adapt Pharma announced that it had submitted an NDA for Narcan naloxone nasal spray, Indivior has announced that the FDA has accepted its naloxone nasal spray NDA for priority review. Indivior says that it expects its product to be the first intranasal naloxone approved by the FDA for the treatment of opioid overdose, with a response from the agency … [Read more...] about Indivior announces submission of NDA for naloxone nasal spray