Regulatory

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 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 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

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

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

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