Regulatory

Italian startup Plumestars has announced via Twitter that it has received orphan drug status from the EMA for its amikacin dry powder inhaler for the treatment of P. aeruginosa infections in cystic fibrosis patients. https://twitter.com/PlumeStars/status/546688438003826688 According to the company's website, it is also developing a tobramycin DPI. … [Read more...] about Plumestars gets orphan drug designation for amikacin DPI

Accoding to Teva, the FDA has approved the company's QNASL beclomethasone dipropionate HFA nasal spray for the treatment of allergic rhinitis symptoms in children aged 4-11. The supplemental NDA for the pediatric product was accepted by the FDA in May 2013. The children's version of QNASL is a 40 µg formulation; the adult version, which was approved in 2012, is an … [Read more...] about FDA approves QNASL for children

Hovione has announced that the FDA has found its Loures, Portugal manufacturing site to be GMP compliant, although the agency issued a Form 483 citing three inspectional observations. The inspection took place from December 1 to December 5, 2014. In October 2013, the company announced that it had completed a successful FDA inspection of the Loures facility with no … [Read more...] about Hovione announces results of FDA pre-approval inspection

PulmoFlow has announced that the FDA has approved its NDA for Kitabis Pak, generic tobramycin inhalation solution packaged with a PARI LC PLUS nebulizer, for the treatment P. aeruginosa infections in cystic fibrosis patients. PARI Respiratory Equipment will distribute the product, which will be priced similarly to generic tobramycin alone, the company said. In … [Read more...] about FDA approves PulmoFlow’s Kitabis Pak for CF

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