Regulatory
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On April 2, 2014, the FDA issued a draft guidance for fentanyl citrate nasal spray. The guidance offers an in vitro option, saying, “If the test product is qualitatively (Q1) and quantitatively (Q2) the same… Read more . . .
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The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) has voted in favor of MannKind’s Afrezza inhaled insulin for both Type 1 and Type 2 diabetes. The vote was 13-1 in agreement that the product… Read more . . .
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Meeting documents for the upcoming April 1 meeting of the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) on MannKind’s Afrezza inhaled insulin include questions about the efficacy of Afrezza compared to subcutaneous insulin and… Read more . . .
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Summit Biosciences has announced the successful completion of an FDA preapproval inspection of its Lexington, KY manufacturing facility. The company, a spin-off of the University of Kentucky College of Pharmacy, said that the inspection is… Read more . . .
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Contract research organization Next Breath has announced that it has been certified as a Center for Pharmaceutical Equivalence (EQFAR) by the Brazilian National Health Surveillance Agency (ANVISA) subsequent to a week-long audit of its quality… Read more . . .
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Avanir Pharmaceuticals has announced that the FDA has accepted its new drug application for the company’s AVP-825 dry powder intranasal sumatriptan for the treatment of migraine headaches. The 505(b)(2) NDA was filed in January 2014.… Read more . . .
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According to Sandoz, South Korea has approved 50 mcg/250 mcg and 50 mcg/500 mcg dosages of the AirFluSal Forspiro salmeterol/fluticasone DPI for the treatment of asthma and COPD. The marketing authorization is the first for… Read more . . .
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According to an FDA spokesperson, the FDA Nonprescription Drugs Advisory Committee (NDAC) and Pulmonary Allergy Drugs Advisory Committee (PADAC) voted not to support approval of Armstrong Pharmaceuticals’ NDA for Primatene HFA during a joint meeting… Read more . . .
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Shortly after announcing that the EMA’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion regarding Anoro umeclidinium/vilanterol, GSK has announced that CHMP also issued a positive opinion regarding umeclidinium monotherapy. According… Read more . . .
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According to Teva, the company’s DuoResp Spiromax budesonide/formoterol fumarate inhalation powder has received a positive opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP). The company has applied to market the product… Read more . . .
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