Regulatory

Mundipharma has announced that its license variation application to extend the use of the Flutiform fluticasone propionate/formoterol MDI to asthma patients aged 5 up to 12 years for whom an ICS/LABA combination is appropriate has received a positive opinion. Flutiform has been approved in Europe for the treatment of asthma in patients 12 and older since 2012. The … [Read more...] about Flutiform okayed for pediatric use in Europe

Eight years after being phased out at the end of 2011 due to its CFC propellant, Amphastar Pharmaceuticals' Primatene Mist epinephrine MDI has been reinstated by the FDA as the only asthma inhaler approved for over the counter sales in the US. The approval is limited to the temporary relief of mild, intermittent asthma symptoms in people aged 12 and over. The new … [Read more...] about FDA approves OTC Primatene Mist for mild asthma

According to AstraZeneca, the EMA's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion regarding the marketing authorization application for the company's Bevespi Aerosphere glycopyrronium/formoterol fumarate MDI for the treatment of COPD. Bevespi Aerosphere was approved by the FDA for marketing in the US in 2016. The MDI is also … [Read more...] about CHMP adopts positive opinion regarding Bevespi Aerosphere MAA

The FDA has approved labeling and indication changes for Boehringer Ingelheim's Stiolto Respimat tiotropium/olodaterol SMI, adding data about reductions in COPD exacerbations to the label. Stiolto Respimat (marketed in Europe as Spiolto Respimat) was initially approved in the US in 2015, with the indication limited to the treatment of airflow limitation in COPD … [Read more...] about FDA approves sNDA for Stiolto Respimat

Janssen Pharmaceutical has submitted an MAA to the EMA for its esketamine nasal spray for the treatment of treatment-resistant depression in adults with major depressive disorder, the company said. Janssen submitted an NDA for the nasal spray to the FDA in September 2018. Janssen Global Head Research & Development Mathai Mammen said, “Major depressive disorder … [Read more...] about Janssen submits MAA for esketamine nasal spray

According to California-based start-up CounterAct, the FDA has approved of the company's approach regarding potential approval of its naloxone nasal spray cap. The CounterAct cap is a plastic device that snaps onto the top of a prescription bottle. In the event of an opiate overdose, the top of the cap is removed, allowing a spray nozzle to fold out to deliver a dose … [Read more...] about FDA clarifies regulatory pathway for CounterAct’s naloxone nasal spray cap

The FDA has approved Insmed's amikacin liposome inhalation suspension for the treatment of nontuberculous mycobacterial (NTM) lung disease caused by Mycobacterium avium complex (MAC) in a limited population of patients. Arikayce, which Insmed had recently been referring to as ALIS, is delivered using PARI's Lamira nebulizer system. According to Insmed, Arikayce will … [Read more...] about FDA approves Arikayce amikacin liposome inhalation suspension (ALIS)

According to Neurelis, the company has submitted an NDA for its diazepam nasal spray, now called Valtoco, for the treatment of cluster seizures in epilepsy patients aged six years and older. The nasal spray, previously known as NRL-1, was granted orphan drug designation in December 2015 and Fast Track designation in December 2016. Neurelis President and CEO Craig … [Read more...] about Neurelis submits NDA for Valtoco diazepam nasal spray