Regulatory

Evoke Pharma said that it has received minutes from a July 25, 2019 Type A meeting with the FDA and that the company now plans to resubmit its NDA for Gimoti metoclopramide nasal spray for the treatment of diabetic gastroparesis in the fourth quarter of 2019. The company initially submitted the NDA in June 2018; in April 2019, the agency issued a CRL in response to … [Read more...] about Evoke anticipates resubmitting Gimoti NDA by the end of 2019

According to Acorda Therapeutics, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion regarding Inbrija inhaled dry powder levodopa for the treatment of motor fluctuations (OFF periods) in Parkinson's disease patients treated with a levodopa/dopa-decarboxylase inhibitor. The marketing authorization … [Read more...] about CHMP issues positive opinion regarding Inbrija

The FDA has announced that it approved Eli Lilly and Company's Baqsimi single-use intranasal dry powder glucagon for the emergency treatment of severe hypoglycemia. Lilly announced that it had submitted the NDA for Baqsimi in July 2018. The company, which acquired worldwide rights to the nasal glucagon powder from Locemia in 2015, said at the time that it had also … [Read more...] about FDA approves Lilly’s Baqsimi intranasal glucagon (updated)

The FDA has issued a final guidance titled "Postmarketing Safety Reporting for Combination Products Guidance for Industry and FDA Staff" that specifies how to comply with postmarketing safety reporting (PMSR) requirements for combination products issued in 2016. The guidance cites several examples of combination product applicants subject to the rule, including "A … [Read more...] about FDA issues final guidance on postmarket safety reports for combination products

Penthrox methoxyflurane inhaler maker Medical Developments International said that it recently met with the FDA regarding the agency's August 2018 clinical hold letter on Penthrox, and the company now has a path forward to resolve the issues. Penthrox is already approved in Australia, Canada, and the majority of Europe. According to MVP, the FDA has dropped a … [Read more...] about MVP says it expects to respond to clinical hold on Penthrox by early 2020

Aridis Pharmaceuticals said that the EMA has granted orphan drug designation to the company's AR-501 inhaled gallium citrate for the treatment of pulmonary infections in cystic fibrosis patients. The company said that the FDA had also recently granted orphan drug designation to AR-501, also known as "Panaecin," for that indication. A Phase 1/2a study of AR-501 is … [Read more...] about EMA grants orphan drug designation to Aridis’ AR-501 inhaled gallium citrate

The FDA has approved low, medium, and high dose versions of Teva's AirDuo Digihaler fluticasone propionate/salmeterol digital DPI for the treatment of asthma, the company said. The inhaler should be available in the US sometime next year. AirDuo Respiclick has been approved by the FDA since January 2017 and was launched in the US in April of that year. The … [Read more...] about Teva’s AirDuo Digihaler approved by the FDA

Insys Therapeutics, which recently filed for bankruptcy, said that the FDA has accepted its NDA for the company's single unit dose naloxone nasal spray. In December 2018, Insys said that it planned to submit NDAs for both the naloxone nasal spray and an epinephrine nasal spray in 2019. Insys Chief Scientific Officer Venkat Goskonda said, “The FDA’s acceptance of … [Read more...] about FDA accepts Insys NDA for naloxone nasal spray