MAP Pharmaceuticals has submitted a new drug application (NDA) to the US FDA for its Levadex inhaled dihydroergotamine (DHE) for the treatment of migraines. The delivery device used for the product is the company's proprietary breath-activated MDI, the Tempo inhaler. MAP recently published data from its Phase 3 FREEDOM-301 trial, in which Levadex met all 4 primary … [Read more...] about MAP Pharmaceuticals submits NDA for Levadex
Regulatory
CHMP issues negative opinion on Pharmaxis’s Bronchitol
Members of the Committee for Medicinal Products for Human Use (CHMP) have indicated that they would vote against approval of Pharmaxis's marketing application for Bronchitol as a treatment for cystic fibrosis (CF). The CHMP took the trend vote after hearing an oral presentation by Pharmaxis regarding the application at its meeting last week. The official vote to … [Read more...] about CHMP issues negative opinion on Pharmaxis’s Bronchitol
MannKind reveals details of latest FDA review meeting
Five days after its end of review meeting with the FDA on May 4 regarding its Afrezza inhaled insulin, MannKind Corporation held a conference call to update its progress and financial situation. During the call, Alfred Mann characterized the meeting as "positive and collaborative, resulting in a redirection of the Type 2 trial that should enable us to support use of … [Read more...] about MannKind reveals details of latest FDA review meeting
Hovione announces successful GMP inspections
Over the past 8 months, says API developer and manufacturer Hovione, its facilities have undergone a total of 6 inspections by the US FDA, the Japanese PMDA, and the Portuguese authorities. Pre-approval inspections for 2 new products for customer synthesis, and for existing molecules used in new formulations, took place at the company's facilities in New Jersey, … [Read more...] about Hovione announces successful GMP inspections
FDA will not appeal ruling on electronic cigarettes
The US FDA has issued a letter informing stakeholders that it will not appeal a December 2010 ruling by the US Court of Appeals for the DC Circuit that the agency has no authority to regulate electronic cigarettes as drug/device combinations unless the manufacturers marketed the products for "therapeutic" use. According to the agency, it intends to take actions … [Read more...] about FDA will not appeal ruling on electronic cigarettes
Sprix nasal spray unaffected by Luitpold shutdown
According to Luitpold Pharmaceuticals, its suspension of both manufacturing at its Shirley, NY facility and distribution of products manufactured at that location, will not affect Sprix ketorolac tromethamine nasal spray. The company says that it voluntarily stopped production prior to an April 14 meeting with the FDA to follow up on recent inspections and agreed to … [Read more...] about Sprix nasal spray unaffected by Luitpold shutdown
New date for MannKind end-of-review meeting
The FDA has rescheduled its end-of-review meeting with MannKind Corporation regarding Afrezza inhaled insulin for May 4, 2011. The agency had earlier cancelled the meeting, which had been scheduled for April 15, due to a potential government shutdown. At one time, the FDA had planned to complete its review by December 29, 2010 but requested additional time to … [Read more...] about New date for MannKind end-of-review meeting
TOBI Podhaler gets market authorization in Canada
Novartis Canada has announced that it has received a Notice of Compliance from Health Canada for its TOBI Podhaler tobramycin DPI for the treatment of Pseudomonas aeruginosa infections in cystic fibrosis patients. The product has been approved for CF patients aged six and older. The TOBI Podhaler has had orphan drug designation in the EU since 2003. According to … [Read more...] about TOBI Podhaler gets market authorization in Canada
Meda submits NDA for Dymista
Soon after announcing positive Phase 3 results for Dymista and saying that it would file an NDA for the product by mid-2011, Meda announced that it has gone ahead with the filing. Dymista is a fixed combination azelastine hydrochloride and fluticasone propionate nasal spray for the treatment of seasonal allergic rhinitis. In the most recent announcement, Meda has … [Read more...] about Meda submits NDA for Dymista
FDA extends review period for QAB149 (indacaterol)
The FDA has informed Novartis that it needs a three-month extension for its review of data supporting the company's NDA for QAB149 (indacaterol). The new completion date for the review would be July 2011. The agency's Pulmonary-Allergy Drugs Advisory Committee (PADAC) recently voted in favor of approving a 75 mcg dose of the drug but against approval of a 150 mcg … [Read more...] about FDA extends review period for QAB149 (indacaterol)