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
Regulatory
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
FDA clears IND for Phase 2 study of Pulmazole itraconazole DPI
The FDA has cleared Pulmatrix's investigational new drug application, giving the company the go-ahead to begin a Phase 2 clinical trial of Pulmazole (PUR1900) inhaled dry powder itraconazole for the treatment of allergic bronchopulmonary aspergillosis (ABPA) in asthma patients. In November 2018, Pulmatrix said that it planned to initiate a Phase 2 trial by the end … [Read more...] about FDA clears IND for Phase 2 study of Pulmazole itraconazole DPI
AIT Therapeutics gets milestone payment from Circassia on completion of pre-submission meeting for AirNOvent
AIT Therapeutics said that it has received a $3.15 million milestone payment from Circassia Pharmaceuticals after successful completion of a pre-submission meeting with the FDA for AirNOvent nitric oxide delivery system. Circassia recently announced that it had acquired US and Chinese rights to the product. In a separate announcement, Circassia said that it will … [Read more...] about AIT Therapeutics gets milestone payment from Circassia on completion of pre-submission meeting for AirNOvent
FDA approves Mylan’s generic version of Advair Diskus
The FDA announced that it has approved Mylan's generic version of Advair Diskus fluticasone propionate/salmeterol DPI for the treatment of asthma in patients four years old and older and for the treatment of COPD. Three strengths were approved: FP 100 μg/salmeterol 50 μg, FP 250 μg/salmeterol 50 μg and FP 500 μg/salmeterol 50 μg. In 2013, the FDA issued a draft … [Read more...] about FDA approves Mylan’s generic version of Advair Diskus
Aradigm announces submission of responses to EMA Day 120 questions
Aradigm Corporation, which submitted an MAA for its dual release inhaled ciprofloxacin for the treatment of chronic P. aeruginosa lung infections in non-cystic fibrosis bronchiectasis (NCFBE) patients in March 2018, has announced that it submitted responses to EMA Day 120 questions on January 23, 2019. The company said that it anticipates receiving a Day 180 list of … [Read more...] about Aradigm announces submission of responses to EMA Day 120 questions
FDA approves Promius’s Tosymra sumatriptan nasal spray
The FDA has approved Promius Pharma's Tosymra sumatriptan nasal spray (formerly known as DFN-02) for the treatment of migraine, Promius parent company Dr. Reddy's has announced. The company submitted an NDA for the nasal spray in April 2018. Dr. Reddy's Laboratories Co-Chairman and CEO G.V. Prasad commented, “We are excited about the approval of Tosymra. This … [Read more...] about FDA approves Promius’s Tosymra sumatriptan nasal spray