The US FDA has granted orphan drug designation to Aradigm Corporation's dual release ciprofloxacin for inhalation (DRCFI) for the treatment of bronchiectasis. The company's liposomal ciprofloxacin for inhalation (CFI) already has orphan drug designation from the FDA for the treatment of bronchiectasis and for cystic fibrosis. The dual release formulation combines … [Read more...] about Aradigm ciprofloxacin for bronchiectasis gets orphan drug designation
Regulatory
Elpen’s Advair copy approved by Sweden
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 not said when or if it will launch the product in European countries outside of Greece. Elpen has been marketing the inhaler … [Read more...] about Elpen’s Advair copy approved by Sweden
FDA accepts NDA for Nycomed nasal aerosol
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 device for the treatment of seasonal allergic rhinitis and perennial allergic rhinitis in patients 12 years old and older. Sunovion (formerly Sepracor) owns the … [Read more...] about FDA accepts NDA for Nycomed nasal aerosol
MAP Pharmaceuticals submits NDA for Levadex
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
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