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 review of the 505(b)(2) NDA submitted by Evoke in June 2018 was April 1, 2019. In March 2019, Evoke announced that it had received a … [Read more...] about Evoke gets CRL for Gimoti
Regulatory
FDA approves Duaklir Pressair for the treatment of COPD
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 sNDA for Tudorza Pressair aclidinium bromide DPI, which has also been approved. The company says that it plans to launch Duaklir in the … [Read more...] about FDA approves Duaklir Pressair for the treatment of COPD
Tudorza sNDA for label change approved
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 in exacerbations and hospitalizations to the inhaler's label. Circassia announced in August 2018 that the FDA had accepted the sNDA for … [Read more...] about Tudorza sNDA for label change approved
FDA advisory committee sets date for meeting to reconsider NDA for Bronchitol DPI
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 resubmitted the NDA in December 2018. Bronchitol was approved for the treatment of CF in Europe in 2012, but the FDA issued a … [Read more...] about FDA advisory committee sets date for meeting to reconsider NDA for Bronchitol DPI
FDA approves Spravato esketamine nasal spray for the treatment of depression
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 risk evaluation and mitigation strategy (REMS). The FDA's Psychopharmacologic Drugs Advisory Committee (PDAC) and Drug Safety and … [Read more...] about FDA approves Spravato esketamine nasal spray for the treatment of depression
FDA expresses concerns about Evoke’s NDA for Gimoti
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 expressed concerns with quality control and reproducibility related to the delivery device, insufficient data supporting differences in … [Read more...] about FDA expresses concerns about Evoke’s NDA for Gimoti
FDA issues new and revised product specific guidances for five nasal sprays
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 the agency, the latest batch of guidances issued includes a total of 74 … [Read more...] about FDA issues new and revised product specific guidances for five nasal sprays
Aradigm says FDA “continues to have concerns” regarding data from Phase 3 trials of Apulmiq
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 from the ORBIT-3 and ORBIT-4 trials of Apulmiq inhaled dual release ciprofloxacin for the treatment of P. aeruginosa lung infections in non-cystic fibrosis … [Read more...] about Aradigm says FDA “continues to have concerns” regarding data from Phase 3 trials of Apulmiq
ARS Pharmaceuticals’ intranasal epinephrine gets Fast Track designation
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 $20 million for clinical development of ARS-1. ARS Pharmaceuticals President and CEO Richard Lowenthal commented, “The FDA’s decision to … [Read more...] about ARS Pharmaceuticals’ intranasal epinephrine gets Fast Track designation
FDA advisory committee recommends approval of Janssen’s intranasal esketamine
The FDA's Psychopharmacologic Drugs Advisory Committee (PDAC) and Drug Safety and Risk Management (DSaRM) Advisory Committee met on February 12, 2019 to consider Janssen's NDA for its esketamine nasal spray for the treatment of treatment-resistant depression in adults and voted in favor of approval. On the question, "Has the Applicant provided substantial evidence … [Read more...] about FDA advisory committee recommends approval of Janssen’s intranasal esketamine