Regulatory
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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… Read more . . .
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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… Read more . . .
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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,… Read more . . .
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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… Read more . . .
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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… Read more . . .
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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… Read more . . .
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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… Read more . . .
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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… Read more . . .
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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… Read more . . .
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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… Read more . . .
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