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… Read more . . .

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… Read more . . .

The FDA has issued a revised draft guidance, “Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Products – Quality Considerations.”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;… Read more . . .

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… Read more . . .

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… Read more . . .

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… Read more . . .

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… Read more . . .

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… Read more . . .

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… Read more . . .

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… Read more . . .