Regulatory

Theravance has announced that the the FDA's Pulmonary-Allergy Drugs Advisory Committee (PADAC) and Drug Safety and Risk Management Advisory Committee will meet jointly on March 19, 2015 to discuss whether the Breo Ellipta fluticasone/vilanterol DPI should be approved for the treatment of asthma in patients 12 and older. Theravance and GSK filed sNDA 204275-S001 in … [Read more...] about FDA advisory committees to review Breo Ellipta sNDA (updated)

Israeli biopharmaceutical company Advanced Inhalation Therapies (AIT) has announced that it received Orphan Drug Designation from the FDA last fall for its AIT-CF high dose nitric oxide formulation for the treatment of lung infections in cystic fibrosis patients. The company says that its proprietary delivery system for the 160 ppm formulation "continuously monitors … [Read more...] about Orphan Drug Designation for AIT’s nitric oxide product for CF

PARI has announced that following approval by the FDA, its eRapid nebulizer is now available for delivery of Pulmozyme dornase alfa inhalation solution for the treatment of cystic fibrosis. In Europe, the device, marketed as eFlow Rapid, has been available for use with Pulmozyme for years. The eRapid nebulizer cuts Pulmozyme delivery time to 2-3 minutes compared … [Read more...] about PARI’s eRapid nebulizer now approved for delivery of Pulmozyme in US

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