Regulatory

Glenmark Pharmaceuticals has submitted an NDA for Ryaltris olopatadine hydrochloride/mometasone furoate nasal spray for the treatment of seasonal allergic rhinitis in patients aged 12 and older, the company said. In December 2017, the company announced that a Phase 3 trial of Ryaltris (GSP 301) had met its primary endpoint. Glenmark Pharmaceuticals President … [Read more...] about Glenmark submits NDA for Ryaltris nasal spray

According to GSK, the FDA has approved the company's sNDA for the use of Arnuity Ellipta fluticasone furoate DPI for the treatment of asthma in children aged 5-11 years. Arnuity Ellipta was approved by the FDA in 2014 for the treatment of asthma in patients 12 years old and older. GSK submitted the sNDA for pediatric use in July 2017. The new approval is for a … [Read more...] about FDA approves Arnuity Ellipta for pediatric use

The FDA has accepted Insned's NDA for ALIS (amikacin liposome inhalation suspension) for the treatment of nontuberculous mycobacterial (NTM) lung infections caused by Mycobacterium avium complex (MAC), with a PDUFA date of September 28, 2018, the company said. Insmed announced submission of the NDA in March 2018. Insmed President and CEO Will Lewis commented, "We … [Read more...] about Insmed’s NDA for ALIS accepted by the FDA

The FDA informed Perrigo during a May 10, 2018 teleconference that the agency will issue a complete response letter to the company's ANDA for its generic version of Teva's ProAir albuterol MDI, Perrigo said. As a result, the company no longer expects to launch its albuterol inhaler by the end of 2018. Perrigo filed an ANDA for the generic version of ProAir in … [Read more...] about Perrigo expects CRL for albuterol MDI ANDA

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