Regulatory
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According to Synspira Therapeutics, the company’s SNSP113 inhaled glycopolymer for the treatment of cystic fibrosis has received orphan drug desination from the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP). The FDA granted… Read more . . .
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According to Evoke Pharma, the FDA has issued a complete response letter in response to the company’s NDA for Gimoti metoclopramide nasal spray for the treatment of diabetic gastroparesis. The PDUFA date for completion of… Read more . . .
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The FDA has approved Duaklir Pressair aclidinium bromide/formoterol fumarate DPI for the treatment of COPD, Circassia Pharmaceuticals has announced. Circassia said in August 2018 that the FDA had accepted the NDA for Duaklir and an… Read more . . .
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According to Circassia Pharmaceuticals, the FDA has approved the company’s sNDA for the addition of data from the Phase 4 ASCENT study of the Tudorza Pressair aclidinium bromide DPI in COPD patients showing significant reduction… Read more . . .
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The FDA’s Pulmonary-Allergy Drugs Advisory Committee (PADAC) will meet on May 8, 2019 to consider Chiesi’s NDA for Bronchitol mannitol DPI for the treatment of cystic fibrosis. According to Bronchitol developer Pharmaxis, its partner Chiesi… Read more . . .
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The FDA announced that it has approved Janssen’s NDA for Spravato esketamine nasal spray for the treatment of treatment-resistant depression. Spravato is to be used with an oral antidepressant and distribution will restricted under a… Read more . . .
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Evoke Pharma said that it has received a multi-disciplinary review letter from the FDA regarding its NDA for Gimoti metoclopramide nasal spray for the treatment of diabetic gastroparesis in adult women. According to Evoke, the letter… Read more . . .
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The FDA has issued a new product-specific guidance for dihydroergotamine mesylate nasal spray and revised guidances for fluticasone propionate; azelastine hydrochloride/fluticasone propionate; mometasone furoate; and triamcinolone acetonide nasal sprays since February 1, 2019. According to… Read more . . .
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Aradigm Corporation, which recently announced that it has filed for bankruptcy, said that it held a Type B meeting with the FDA on January 25, 2019 at which the agency expressed continued concerns about data… Read more . . .
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ARS Pharmaceuticals said that the FDA has granted Fast Track designation to its ARS-1 intranasal epinephrine, which is in development for the treatment of anaphylaxis. In December 2018, the company announced that it had raised… Read more . . .
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October 14-October 15: Advancing Bioequivalence Frameworks for Inhalation and Nasal Drug Products: Optimizing In Vitro, In Vivo, and In Silico Methods, Rockville, MD, USA