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
Regulatory
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
Adapt Pharma submits NDA for Narcan nasal spray
Adapt Pharma has submitted an NDA for Narcan naloxone nasal spray for the treatment of opioid overdose to the FDA, the company has announced. In June 2015, Adapt said that it had initiated a rolling NDA submission. Adapt Chairman and CEO Seamus Mulligan commented, “If FDA approved, Narcan Nasal Spray would allow for the administration of naloxone - the standard … [Read more...] about Adapt Pharma submits NDA for Narcan nasal spray
Propeller Health’s inhaler monitoring platform approved for use with Diskus and Respimat
Propeller Health has received 510(k) clearance from the FDA to market the Propeller inhaler monitoring platform for use with the Diskus DPI and with the Respimat SMI, the company announced. Two versions of the Propeller platform have previously been approved for use with MDIs, most recently in 2014. The platform includes Bluetooth-enabled sensors that snap onto … [Read more...] about Propeller Health’s inhaler monitoring platform approved for use with Diskus and Respimat
Amneal’s generic version of Tobi inhalation solution approved by FDA
The FDA has approved Amneal Pharmaceuticals's generic version of Tobi tobramycin inhalation solution, the company said. The product is the New Jersey-based generic pharmaceutical company's first inhalation solution. Amneal co-CEO and Chairman Chirag Patel said, "Tobramycin is extremely exciting for us in that it’s a new dosage form for Amneal—proof we’re … [Read more...] about Amneal’s generic version of Tobi inhalation solution approved by FDA
FDA issues product-specific guidances for several OINDPs
The FDA has issued product-specific recommendations for demonstrating the bioequivalence of over 40 drug products, including several OINDPs. The newly added documents include guidances for azelastine HCL/fluticasone propionate nasal spray, budesonide/formoterol fumarate MDI, and levalbuterol tartrate MDI. Comments on the new guidances can be submitted to the FDA … [Read more...] about FDA issues product-specific guidances for several OINDPs
Spiolto Respimat approved in a number of European countries
According to Boehringer Ingelheim, the United Kingdom, Croatia, Slovakia, Denmark, Norway, Ireland, Austria, Romania and Spain have approved the Spiolto Respimat tiotropium/olodaterol SMI for the treatment of COPD. BI recently announced the launch of the tiotropium/olodaterol soft mist inhaler in the US, where it is marketed as Stiolto Respimat. Boehringer … [Read more...] about Spiolto Respimat approved in a number of European countries