California-based Innovus Pharmaceuticals announced that it has signed a manufacturing agreement for its FlutiCare fluticasone propionate nasal spray in anticipation of FDA approval, which it expects in the 3rd quarter of 2016. No details were revealed. The company acquired rights to the nasal spray in February 2015; an ANDA for the OTC version had been filed by … [Read more...] about Innovus Pharmaceuticals updates on plans for OTC FlutiCare nasal spray
Regulatory
Teva says DCP for Braltus tiotropium DPI results in “positive conclusion”
According to Teva Pharmaceutical, a decentralized procedure for its Braltus tiotropium bromide DPI for the treatment of COPD has reached "a positive conclusion." The tiotropium formulation is delivered using the new Zonda inhaler, the company said. No additional information was released other than the company's statement that "National Marketing Authorizations and … [Read more...] about Teva says DCP for Braltus tiotropium DPI results in “positive conclusion”
Perrigo and Hikma get FDA approval for and launch generic fluticasone propionate nasal spray
Perrigo and Hikma subsidiary West-Ward Pharmaceuticals have launched an OTC fluticasone propionate nasal spray, a generic version of Flonase, in the US after receiving approval for the product from the FDA, the companies said. The nasal spray will be marketed under store brand names. Flonase was approved for over-the-counter sales in the US in 2014. Hikma … [Read more...] about Perrigo and Hikma get FDA approval for and launch generic fluticasone propionate nasal spray
FDA issues new draft guidance for developing COPD drugs
The FDA has issued a new draft guidance titled "Chronic Obstructive Pulmonary Disease: Developing Drugs for Treatment," a revision of a 2007 draft guidance with the same title. Among other changes, the 2016 revision includes an appendix regarding use of the St. George’s Respiratory Questionnaire (SGRQ) in COPD studies. In the Federal Register announcement, the … [Read more...] about FDA issues new draft guidance for developing COPD drugs
FDA approves ProAir RespiClick for pediatric use
The FDA has approved Teva's supplemental NDA for ProAir RespiClick albuterol breath-activated DPI for the treatment or asthma in children aged 4 to 11, the company has announced. The sNDA filing was accepted by the FDA in September 2015. ProAir RespiClick has been approved by the FDA for patients 12 years old and older since March 2015. Erwin Gelfand, Chairman, … [Read more...] about FDA approves ProAir RespiClick for pediatric use
AstraZeneca’s Bevespi Aerosphere MDI approved by the FDA
The FDA has approved AstraZeneca's Bevespi Aerosphere glycopyrrolate/formoterol fumarate MDI (formerly PT003) for the treatment of COPD, the company has announced. The product is AstraZeneca's first to use the Co-Suspension technology patented by Pearl Therapeutics in 2012. AstraZeneca acquired Pearl in 2013. Data from the Phase 3 PINNACLE trial, which was … [Read more...] about AstraZeneca’s Bevespi Aerosphere MDI approved by the FDA
FDA issues product-specific draft guidances for four more inhalation products
The US FDA has issued four new product-specific draft guidances in April 2016 for inhalation products, including three dry powder products and one MDI. The documents include recommendations on establishing bioequivalence for generic versions of Breo/Relvar Ellipta, Arnuity Ellipta, Arcapta Neohaler/Onbreez Breezhaler, and Asmanex HFA, Read the new guidances for … [Read more...] about FDA issues product-specific draft guidances for four more inhalation products
FDA warns online retailer over unapproved epinephrine DPI
On March 10, 2016, the Philadelphia District Office of the FDA issued a warning letter to online retailer Dr Natural Healing about sales of epinephrine capsules packaged with a dry powder inhaler as a treatment for asthma. The letter gives the company 15 working days to respond. As of March 31, the website is still offering the "Prime Asthma Relief" products for sale, … [Read more...] about FDA warns online retailer over unapproved epinephrine DPI
Mundipharma submits MAA for flutiform K-Haler breath-activated MDI
Mundipharma has submitted a marketing application to the UK Medicines and Healthcare products Regulatory Agency (MHRA) for the flutiform fluticasone/formoterol K-Haler breath-activated MDI for the treatment of asthma, the company said. The submission will be reviewed through the decentralized procedure. In 2006, Mundipharma acquired European rights to flutiform … [Read more...] about Mundipharma submits MAA for flutiform K-Haler breath-activated MDI
FDA approves sNDA for Stiolto Respimat
According to Boehringer Ingelheim Pharmaceuticals, the FDA has approved a supplemental NDA for the Stiolto Respimat tiotropium/olodaterol SMI for a labeling change to add quality of life data obtained from the OTEMTO 1&2 studies. Stiolto Respimat, which was initially approved for the treatment of COPD by the FDA in May 2015, is approved as Spiolto Respimat in some … [Read more...] about FDA approves sNDA for Stiolto Respimat