Regulatory

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

The Canadian Agency for Drugs and Technology in Health (CADTH) has issued a call for patient input regarding GSK's Breo Ellipta fluticasone furoate/vilanterol DPI for the treatment of asthma. According to the announcement, the agency has received notice of a pending submission and is seeking input from patient groups for purposes of a Common Drug Review. According … [Read more...] about Canadian agency calls for patient input on Breo Ellipta

Impax Specialty Pharma has received approval from the FDA to market Zomig zolmitriptan nasal spray for the treatment of migraine in patients 12-17 years of age, the company says. Impax acquired the US rights to Zomig nasal spray from AstraZeneca in 2012. Impax Laboratories President and CEO Fred Wilkinson commented, "Treatment options have been limited for … [Read more...] about FDA approves Zomig nasal spray for pediatric patients

Adapt Pharma has initiated a rolling NDA submission for intranasal naloxone for the treatment of opioid overdose, the company said. Adapt licensed the intranasal naloxone formulation from Lightlake Therapeutics in December 2014 and received Fast Track Designation for the product from the FDA in February 2015. Lightlake CEO Roger Crystal said, "This is a very … [Read more...] about Adapt Pharma initiates rolling NDA submission for intranasal naloxone

According to Boehringer Ingelheim, the FDA has approved its tiotropium bromide/olodaterol soft mist inhaler for the treatment of COPD. The company filed an NDA for the product, which will be marketed as Stiolto Respimat Inhalation Spray, in August 2014. New data analyses from Phase 3 studies showing improved lung function for patients using the combination … [Read more...] about FDA approves Stiolto Respimat for the treatment of COPD

Advanced Inhalation Therapies (AIT) has announced that its AIT-CF high dose inhaled formulation of nitric oxide (NO) for the treatment of cystic fibrosis has been granted orphan medical product designation by the European Commission. In February 2015, the company announced that the product had received orphan drug designation from the FDA in late 2014. AIT Chief … [Read more...] about AIT’s nitric oxide product for CF gets European orphan designation

The FDA has approved GSK's supplemental NDA for the Breo Ellipta fluticasone furoate/vilanterol DPI, allowing GSK to market the inhaler for the treatment of asthma in patients aged 18 years and older. Breo Ellipta was approved by the FDA for the treatment of COPD in May 2013. In March 2015, the FDA’s Pulmonary-Allergy Drugs Advisory Committee (PADAC) and Drug … [Read more...] about FDA approves Breo Ellipta for the treatment of asthma in adults