Regulatory

The FDA has granted orphan drug designation to a ciprofloxacin DPI being developed by Bayer HealthCare for the treatment of non-cystic fibrosis bronchiectasis, the company has announced. The dry powder formulation, based on Novartis's PulmoSphere platform, is delivered using the T-326 (Podhaler) DPI. The product is currently in Phase 3 trials. Bayer is also … [Read more...] about Bayer ciprofloxacin DPI gets orphan drug status from the FDA

Canada has approved GSK's Incruse Ellipta umeclidinium (UMEC) DPI for the once-daily treatment of COPD, the first approval for its UMEC monotherapy, the company said. GSK received a positive opinion from the EMA's Committee for Medicinal Products for Human Use (CHMP) regarding its MAA for Incruse Ellipta in February 2014, and the company submitted an NDA for the … [Read more...] about Incruse Ellipta approved in Canada

The FDA has extended the Prescription Drug User Fee Act (PDUFA) date for MannKind's Afrezza inhaled insulin by three months, according to MannKind. The original date was April 15, 2014; the new date is July 15, 2014. The agency's Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) recommended approval of Afrezza on April 2, 2014. The delay was … [Read more...] about PDUFA date for Afrezza now July 15, 2014

On April 2, 2014, the FDA issued a draft guidance for fentanyl citrate nasal spray. The guidance offers an in vitro option, saying, "If the test product is qualitatively (Q1) and quantitatively (Q2) the same as the reference product, then bioequivalence may be documented by an in vitro approach in lieu of an in vivo approach." If bioequivalence cannot be … [Read more...] about FDA issues draft guidance for fentanyl citrate nasal spray

The FDA's Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) has voted in favor of MannKind's Afrezza inhaled insulin for both Type 1 and Type 2 diabetes. The vote was 13-1 in agreement that the product is safe and effective for Type 1 diabetes, with 1 abstention; 14 -0 in agreement that it is safe and effective for Type 2 diabetes. MannKind Chairman and … [Read more...] about FDA advisory committee votes in favor of Afrezza inhaled insulin

Meeting documents for the upcoming April 1 meeting of the FDA's Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) on MannKind's Afrezza inhaled insulin include questions about the efficacy of Afrezza compared to subcutaneous insulin and about data showing that use of the product reduces lung function over time. Discussion topics for the meeting … [Read more...] about FDA advisory committee document raises questions about Afrezza efficacy, safety

Summit Biosciences has announced the successful completion of an FDA preapproval inspection of its Lexington, KY manufacturing facility. The company, a spin-off of the University of Kentucky College of Pharmacy, said that the inspection is for a new nasal spray. In early 2011, Summit announced that it had received a federal grant for development of a synthetic THC … [Read more...] about Summit Biosciences announces successful preapproval inspection for nasal spray

Avanir Pharmaceuticals has announced that the FDA has accepted its new drug application for the company's AVP-825 dry powder intranasal sumatriptan for the treatment of migraine headaches. The 505(b)(2) NDA was filed in January 2014. According to Avanir, the PDUFA goal date is November 26, 2014. AVP-825 was developed by OptiNose for delivery using OptNose's … [Read more...] about Avanir announces acceptance of its NDA for AVP-825 dry powder intranasal sumatriptan

According to Sandoz, South Korea has approved 50 mcg/250 mcg and 50 mcg/500 mcg dosages of the AirFluSal Forspiro salmeterol/fluticasone DPI for the treatment of asthma and COPD. The marketing authorization is the first for AirFluSal Forspiro in Asia. A number of European countries have approved the inhaler, including Germany, Belgium, Sweden, Norway, Hungary, … [Read more...] about South Korea approves AirFluSal Forspiro