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 guidances to foster drug product development, and ANDA submission and approval, ultimately providing increased access to safe, … [Read more...] about FDA issues revised draft guidances for sumatriptan and zolmitriptan nasal sprays

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 months to 8 years. Other companies with approved ANDAs for budesonide inhalation suspension 0.5 mg/2 mL include Apotex (licensed to Nephron), … [Read more...] about FDA approves Lupin budesonide inhalation suspension

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 for review in January 2018. The two companies announced in 2015 that they would partner to develop revefenacin, then known as TD-4208, as an … [Read more...] about FDA approves Yupelri revefenacin inhalation solution for COPD

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 relief of symptoms with a dual bronchodilator. Trelegy Ellipta was approved in Europe in 2017 for COPD patients not … [Read more...] about Trelegy Ellipta gets expanded indication for COPD in Europe

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 received a positive opinion. Flutiform has been approved in Europe for the treatment of asthma in patients 12 and older since 2012. The … [Read more...] about Flutiform okayed for pediatric use in Europe

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 over the counter sales in the US. The approval is limited to the temporary relief of mild, intermittent asthma symptoms in people aged 12 and over. The new … [Read more...] about FDA approves OTC Primatene Mist for mild asthma

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 COPD. Bevespi Aerosphere was approved by the FDA for marketing in the US in 2016. The MDI is also … [Read more...] about CHMP adopts positive opinion regarding Bevespi Aerosphere MAA

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 approved in the US in 2015, with the indication limited to the treatment of airflow limitation in COPD … [Read more...] about FDA approves sNDA for Stiolto Respimat