Regulatory
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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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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.… Read more . . .
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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… Read more . . .
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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… Read more . . .
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Briefing materials prepared by the FDA for the Pulmonary-Allergy Drugs Advisory Committee (PADAC) meeting scheduled for March 8, 2011 ask committee members to consider the safety of the higher dose of Novartis’s indacaterol inhalation powder.… Read more . . .
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Pharmaxis has received TGA approval to market its Bronchitol inhaled dry powder mannitol in Australia for the treatment of cystic fibrosis. The approval is for patients over 6 years old. Bronchitol received orphan drug designation… Read more . . .
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AstraZeneca has announced that it has received marketing authorization from the European Commission for its Fluenz nasal spray vaccine for the prevention of seasonal flu in children under 18 years old down to 24 months… Read more . . .
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MannKind Corporation has again received a complete response letter from the FDA in regards to its application for Afrezza inhaled insulin. A previous CRL was issued in March 2010, and the company resubmitted the NDA… Read more . . .
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According to Alexza Pharmaceuticals, it plans to resubmit its NDA for AZ-004 (Staccato loxapine) for the treatment of agitation in schizophrenic patients in July 2011. The company received a complete response letter (CRL) for the… Read more . . .
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