Regulatory

According to Avanir Pharmaceuticals, it has received a Complete Response Letter (CRL) from the FDA regarding its New Drug Application (NDA) for AVP-825 intranasal sumatriptan for the treatment of migraine. The company had recently warned that its NDA was unlikely to be approved by the PDUFA date due to FDA concerns about human factors issues. In the CRL, "the FDA … [Read more...] about Avanir gets Complete Response Letter for intranasal sumatriptan

According to Bayer, its Amikacin Inhale inhalation solution and its ciprofloxacin DPI have both been granted qualified infectious disease product (QIDP) designation by the FDA. Both products are currently in Phase 3 development. Bayer HealthCare Pharmaceuticals VP and Head Dario Mirski commented, "We welcome the QIDP designation for Ciprofloxacin DPI and Amikacin … [Read more...] about QIDP designation for two Bayer inhaled antibiotics

According to AstraZeneca, the European Commission has approved the Duaklir Genuair aclidinium bromide/formoterol fumarate DPI for the treatment of COPD. The EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended approval of the product in September 2014, and AstraZeneca acquired the rights to commercialize the inhaler in the EU when it acquired … [Read more...] about Duaklir Genuair gets European marketing authorization

According to Sandoz, Ireland and the Czech Republic have approved marketing applications for the AirFluSal Forspiro salmeterol/fluticasone DPI in 50-250 and 50-500 µg dosage forms for the treatment of asthma and/or COPD. The Czech approval triggers a €1.5 million milestone payment from Sandoz to Vectura. Sandoz Head of Global Respiratory Jan-Torsten Tews said, “We … [Read more...] about Two more approvals for AirFluSal Forspiro

According to Avanir Pharmaceuticals,the FDA has issued a Discipline Review letter in response to the company's NDA for AVP-825 intranasal dry powder sumatriptan requesting that the company "optimize the product-user interface" and conduct additional human factor testing. AVP-825 is delivered using OptiNose's Breath Powdered intranasal delivery device. Although the … [Read more...] about Avanir says NDA for AVP-825 unlikely to be approved by PDUFA date

Accordig to Sandoz, the company has received marketing authorization in Estonia, Latvia and Lithuania for the 50-250 and 50-500 µg dosages of the AirFluSal Forspiro salmeterol/fluticasone DPI for the treatment of asthma and COPD. The inhaler is now approved in 13 European countries, as well as in Mexico and South Korea. Sandoz Head of Global Respiratory Jan-Torsten … [Read more...] about AirFluSal Forspiro approved in three more countries

The Portuguese Health Authority (Infarmed) has approved Sandoz's AirFluSal Forspiro salmeterol/fluticasone DPI for the treatment of asthma and COPD, triggering a €1.5 million milestone payment to developer Vectura. Sandoz licensed AirFluSal Forspiro from Vectura in 2006. The Portuguese approval covers the 50-250 and 50-500 µg dosage forms. AirFluSal Forspiro is now … [Read more...] about Portugal approves AirFluSal Forspiro

Almirall has announced that the EMA's Committee for Medicinal Products for Human Use (CHMP) has recommended approval of the company's aclidinium bromide/formoterol fumarate DPI for the treatment of COPD. Almirall will market the product as Duaklir Genuair and Brimica Genuair in Europe. Almirall Chief Scientific Officer Thomas Eichholtz said, "We are very pleased … [Read more...] about CHMP recommends approval of Duaklir Genuair inhaler

According to Boehringer Ingelheim, the FDA has approved the company's Spiriva Respimat tiotropium bromide inhalation soft mist inhaler for the treatment of COPD. In August 2014, the FDA’s Pulmonary-Allergy Drugs Advisory Committee (PADAC) voted in favor of approval of the SMI. The company said that Spiriva Respimat should be available in January 2015. BI … [Read more...] about FDA approval for Spiriva Respimat