Regulatory

The FDA's Pulmonary‐Allergy Drugs Advisory Committee (PADAC) has voted to recommend approval of Chiesi's NDA for Bronchitol DPI for the treatment of cystic fibrosis in adult patients. According to Bronchitol developer Pharmaxis, Chiesi re-submitted the NDA in December 2018. Bronchitol is already approved in Australia, Russia, and in Europe, where it was okayed in … [Read more...] about PADAC votes to recommend approval of Bronchitol

According to Glenmark Pharmaceuticals, the Russian Ministry of Healthcare has approved the company's Momate Rhino mometasone furoate nasal spray for over-the-counter sales for the treatment of allergic rhinitis in adults. Glenmark Pharmaceuticals Senior VP and Head,"Asia, Russia & CIS region, Csaba Kantor commented, "Glenmark has built strong capabilities in … [Read more...] about Glenmark gets Russian approval for Momate Rhino nasal spray

The FDA has announced the final approval of Teva's ANDA for a generic naloxone hydrochloride nasal spray. According to the announcement, the agency tentatively approved the ANDA in June 2018. Opiant Pharmaceutical's Narcan nasal spray was approved in a 4 mg dose version by the FDA in November 2015, and a 2 mg dose version of Narcan was approved in January 2017. … [Read more...] about FDA approves first generic of Narcan nasal spray

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 orphan drug designation to SNSP113 in October 2018. The company said that it has received funding from … [Read more...] about Synspira’s inhaled glycopolymer for CF gets orphan drug designation in EU

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

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

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

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

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