Regulatory

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

According to GlaxoSmithKline and Innoviva, the EMA's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion regarding wider use of the Trelegy Ellipta fluticasone furoate/umeclidinium/ vilanterol DPI in moderate-to-severe COPD. Trelegy Ellipta was approved in Europe in November 2017 for patients not adequately treated by an ICS and a … [Read more...] about CHMP issues positive opinion regarding expanded use of Trelegy Ellipta

Acorda Therapeutics has announced that the PDUFA date for review of its NDA for the Inbrija levodopa DPI for the treatment of symptoms during OFF periods in Parkinson's disease patients has been changed from October 5, 2018 to January 5, 2019. The company said that the FDA extended the review period because Acorda's submission in response to a request by the … [Read more...] about NDA for Inbrija inhaled levodopa gets new PDUFA date

The FDA has issued dozens of new product-specific draft guidances for generic drug development, including a draft guidance for dry powder formulations of albuterol sulfate. The guidance covers development of generic equivalents to Teva's ProAir RespiClick, which was approved for the treatment of asthma in adults in 2015 and for pediatric use in 2016. The draft … [Read more...] about FDA issues new draft guidance for albuterol sulfate DPIs

Biohaven Pharmaceuticals said that it has filed an investigational new drug application for its BHV-3500 intranasal calcitonin gene-related peptide (CGRP) receptor antagonist, which it is developing for the prevention and treatment of migraine. BHV-3500, which Biohaven licensed from Bristol-Myers Squibb, is delivered using Aptar Pharma's unit dose system. … [Read more...] about Biohaven submits IND for intranasal CGRP receptor antagonist for migraine

Glenmark Pharmaceuticals announced that it has received marketing approval from German authorities for its generic version of Seretide Accuhaler and said that the product will be marketed in Germany as "Salflutin." The company acquired development and marketing rights to the fluticasone/salmeterol DPI from Celon for 15 countries, including the UK, Germany, … [Read more...] about Glenmark’s generic version of Seretide Accuhaler approved in Germany

Johnson & Johnson subsidiary Janssen Pharmaceutical has submitted an NDA for esketamine nasal spray for the treatment of treatment-resistant depression in adults, the company said. Janssen said that it plans to submit an MAA to the EMA for esketamine nasal spray for the same indication later this year. In May 2018, Janssen published positive results from a Phase 3 … [Read more...] about Janssen submits NDA for esketamine nasal spray