Regulatory

Insmed has announced that the FDA’s Division of Antimicrobial Products has set an advisory committee meeting for August 7, 2018 for review of the company’s NDA for ALIS amikacin liposome inhalation suspension for the treatment… Read more . . .

Mylan has announced that it was informed by the FDA on June 13, 2018 that the agency will issue a complete response letter regarding Mylan’s ANDA for its generic Advair Diskus fluticasone/salmeterol DPI on June… Read more . . .

MannKind Corporation has announced that a previously announced Phase 1 study of its Treprostinil Technosphere (TreT) DPI in healthy volunteers has met its primary endpoint of safety and tolerability, and the company is now preparing… Read more . . .

Evoke Pharma has submitted a 505(b)(2) NDA for Gimoti metoclopramide nasal spray for the treatment of acute and recurrent diabetic gastroparesis in adult women, the company said. Earlier this year, Evoke announced that it had… Read more . . .

GSK Australia has announced that the Australian Pharmaceutical Benefits Scheme (PBS) will reimburse for Trelegy Ellipta for the treatment of moderate to severe COPD as of June 1, 2018. According to a document on the… Read more . . .

GSK and Innoviva have announced that an NDA for the Trelegy Ellipta fluticasone furoate/umeclidinium/vilanterol DPI for the treatment of COPD has been submitted to the Japanese Ministry of Health, Labour and Welfare (MHLW). Trelegy Ellipta… Read more . . .

Indian pharma company Sava Healthcare has announced that its DPI capsule manufacturing line has received approval from the Russian Ministry of Health (MOH). Sava said that it manufactures tiotropium, formoterol, salmeterol/fluticasone, and budesonide/formoterol DPIs for… Read more . . .

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… Read more . . .

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… Read more . . .