Regulatory

MannKind Corporation has announced that FDA is no longer requiring a Risk Evaluation and Mitigation Strategy (REMS) communication plan for Afrezza inhaled insulin. Afrezza was approved in the US in June 2014, with the FDA requiring a boxed warning about bronchospasm in asthma and COPD patients and several post-marketing studies. According to the company, the REMS … [Read more...] about FDA no longer requiring REMS communication plan for Afrezza inhaled insulin

According to GlaxoSmithKline and Innoviva, the FDA has approved an expanded indication for the Trelegy Ellipta fluticasone furoate/umeclidinium/vilanterol DPI, allowing the use of Trelegy Ellipta for COPD patients with airflow limitation or with acutely worsening respiratory symptoms. GSK filed an sNDA for Trelegy Ellipta in November 2017 based on data from the … [Read more...] about The FDA approves expanded indication for Trelegy Ellipta

The FDA has issued a revised draft guidance, "Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Products - Quality Considerations." The guidance is scheduled for publication in the Federal Register on April 19, 2018; comments regarding the document should be submitted to the FDA within 60 days of publication. According to a draft of the Federal Register … [Read more...] about FDA issues revised draft guidance for MDI and DPI quality considerations

Penthrox, a methoxyflurane inhaler, has been approved in Canada for short-term relief of moderate to severe pain resulting from trauma or medical procedures, Medical Developments International (MDI) said. The company announced in June 2017 that its marketing authorization application had been accepted for review by Health Canada. Purdue Pharma, acquired Canadian … [Read more...] about Penthrox methoxyflurane inhaler approved in Canada and several European countries

According to GSK and Innoviva, the Trelegy Ellipta fluticasone furoate/umeclidinium/vilanterol DPI has been approved in Canada for the treatment of COPD in patients for whom treatment with an ICS/LABA combination is inadequate. Trelegy Ellipta should be available in Canada sometime in June of this year, the companies said. Trelegy Ellipta was approved in the US in … [Read more...] about Trelegy Ellipta approved in Canada

Dr. Reddy's subsidiary Promius Pharma has submitted an NDA for its DFN-02 intranasal sumatriptan for the treatment of migraine headaches, the company said. The DFN-02 formulation includes Aegis Therapeutics' Intravail absorption enhancer; Aegis received a US patent for formulations of triptans including Intravail in 2012. In June 2016, Promius announced that a … [Read more...] about Promius Pharma submits NDA for intranasal sumatriptan for migraine headaches

Insmed has submitted an NDA for ALIS amikacin liposome inhalation suspension for the treatment of nontuberculous mycobacterial (NTM) lung infections caused by Mycobacterium avium complex (MAC), the company said. In September 2017, Insmed announced that it would seek accelerated approval for ALIS from the FDA based on positive results from the Phase 3 CONVERT … [Read more...] about Insmed submits NDA for ALIS for the treatment of NTM lung infections caused by MAC

According to Adherium, the FDA has okayed over-the-counter (OTC) sales of the company's Smartinhaler sensor for AstraZeneca’s Symbicort MDI. The 510(k) OTC clearance will allow patients to purchase the sensor without a prescription at local pharmacies or online. In 2015, Adherium announced that it had partnered with AstraZeneca to provide sensors for use in the … [Read more...] about Adherium’s Smartinhaler SmartTouch for Symbicort sensor gets 510(k) OTC clearance

Acorda Therapeutics has submitted a marketing authorization application to the EMA for its Inbrija levodopa DPI for the treatment of OFF periods in Parkinson's disease patients, the company said. The application is supported by data from the Phase 3 SPAN-PD trial, which demonstrated improved motor function in Parksinson's patients experiencing OFF periods, and … [Read more...] about Acorda files MAA for Inbrija inhaled levodopa

Orion Corporation has announced that its salmeterol/fluticasone Easyhaler combination DPI has received a positive opinion under the EU's decentralized procedure, with Sweden as the reference member state. Orion had announced in December 2016 that it planned to submit an MAA in early 2017 based on positive results from a PK study. According to Orion, it will now … [Read more...] about Orion gets positive opinion for salmeterol/fluticasone Easyhaler in EU under the decentralized procedure