Regulatory

Revised draft guidances for sumatriptan and zolmitriptan nasal sprays are included in the most recent batch of product-specific guidances for generic drug development issued by the FDA. The agency says that it “publishes these product-specific… Read more . . .

According to Lupin, the FDA has approved its ANDA 0.5 mg/2 mL single dose ampules of budesonide inhalation suspension, a generic version of AstraZeneca’s Pulmicort Respules, for the treatment of asthma in children aged 12… Read more . . .

According to Theravance Biopharma and Mylan, the FDA has approved the NDA for Yupelri revefenacin inhalation solution for the treatment of COPD. The NDA was submitted in November 2017, and the FDA accepted the application… Read more . . .

According to GlaxoSmithKline and Innoviva, the European Commission has approved a label change for the Trelegy Ellipta fluticasone furoate/umeclidinium/vilanterol DPI, extending its use to patients with moderate to severe COPD who do not achieve adequate… Read more . . .

Mundipharma has announced that its license variation application to extend the use of the Flutiform fluticasone propionate/formoterol MDI to asthma patients aged 5 up to 12 years for whom an ICS/LABA combination is appropriate has… Read more . . .

Eight years after being phased out at the end of 2011 due to its CFC propellant, Amphastar Pharmaceuticals’ Primatene Mist epinephrine MDI has been reinstated by the FDA as the only asthma inhaler approved for… Read more . . .

According to AstraZeneca, the EMA’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion regarding the marketing authorization application for the company’s Bevespi Aerosphere glycopyrronium/formoterol fumarate MDI for the treatment of… Read more . . .

The FDA has approved labeling and indication changes for Boehringer Ingelheim’s Stiolto Respimat tiotropium/olodaterol SMI, adding data about reductions in COPD exacerbations to the label. Stiolto Respimat (marketed in Europe as Spiolto Respimat) was initially… Read more . . .