Regulatory
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Reuters is reporting that the Swedish Medical Products Agency has approved a fluticasone/salmeterol DPI manufactured by Greek pharmaceutical company Elpen. The approval apparently took place in May 2011 but was not announced. The company has… Read more . . .
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The US FDA has accepted the filing of the new drug application for its ciclesonide nasal aerosol, according to Nycomed and Sunovion. The product is an HFA formulation of ciclesonide delivered by a metered dose… Read more . . .
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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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