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
Regulatory
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)
Insmed gets clearance for Phase 3 Arikace trial
According to Virginia biotech company Insmed, the US FDA has cleared the company's Investigational New Drug (IND) application for a Phase 3 trial of its Arikace liposomal amikacin for inhalation in nontuberculous mycobacteria lung infections. Arikace is delivered using a custom PARI eFlow nebulizer system. Renu Gupta, Insmed's Executive Vice President Development … [Read more...] about Insmed gets clearance for Phase 3 Arikace trial
FDA committee recommends approval of lower dose of indacaterol
The Pulmonary-Allergy Drugs Advisory Committee (PADAC) of the US FDA has voted to recommend approval of the 75 mcg dose of Novartis's QAB149 indacaterol dry powder formulation for the treatment of COPD but has voted against approval of the 150 mcg dose. The vote was 13 to 4 in favor of the lower dose and 12 to 5 against recommendation of the higher dose. Trevor … [Read more...] about FDA committee recommends approval of lower dose of indacaterol
Phase 3 studies planned for nasal mist dental anesthesia
After a favorable end-of-Phase 2 meeting with the FDA, St. Renatus has announced that it plans to proceed to Phase 3 studies of its dental anesthetic, which is delivered as a nasal mist via a syringe. The nasally-administered anesthetic numbs the patient's teeth without numbing the face and lips. According to St. Renatus, the Phase 2 results showed that the nasal … [Read more...] about Phase 3 studies planned for nasal mist dental anesthesia