Regulatory

According to Lupin, Health Canada has approved the company's generic version of Boehringer Ingelheim's Spiriva tiotropium bromide inhalation powder for the treatment of COPD. In the UK, the MHRA approved the company's Lutio tiotropium DPI for the treatment of COPD in August 2022. Lupin President, Legal, for Canada, Australia, and Japan, Sofia Mumtaz commented, … [Read more...] about Health Canada approves Lupin’s generic of Spiriva tiotropium bromide DPI

The FDA has approved Indivior's Opvee nalmefene nasal spray (OPNT003) for the treatment of opioid overdose, the company announced. Indivior recently acquired the intranasal nalmefene product as part of its acquisition of Opiant Pharmaceuticals. The company said that it expects to launch the nasal spray by the end of 2023. Opiant announced in June 2022 that it had … [Read more...] about FDA approves Indivior’s Opvee nalmefene nasal spray

The FDA recently published a new product specific draft guidance for inhaled dry powder loxapine for development of generic versions of Adasuve loxapine inhalation powder, which was approved by the agency in December 2012 for the treatement of agitation in patients with schizophrenia or bipolar I disorder. All patents covering Adasuve listed in the Orange Book are … [Read more...] about FDA issues new product specific draft guidance for loxapine inhalation powder, revised draft guidances for 9 other OINDPs

Satsuma Pharmaceuticals said that the FDA has accepted the company's 505(b)(2) NDA for STS101 nasal powder dihydroergotamine for the treatment of migraine, and Satsuma expects the agency to set a PDUFA goal date in January 2024. Satsuma recently agreed to be reacquired by Shin Nippon Biomedical Laboratories (SNBL). According to Satsuma, data from the Phase 3 SUMMIT … [Read more...] about FDA accepts Satsuma’s NDA for STS101 intranasal dry powder DHE for the treatment of migraine

The FDA's Pulmonary-Allergy Drug Advisory Committee (PADAC) voted at its May 11, 2023 meeting in support of approval of ARS Pharmaceuticals' Neffy intranasal epinephrine for the treatment of allergic reactions, including anaphylaxis, the company announced. Committee members voted 16-6 that the data supported a favorable risk/benefit assessment for use in adults and … [Read more...] about PADAC votes in favor of approval of ARS Pharmaceuticals’ Neffy intranasal epinephrine

According to Optinose, the FDA has accepted the company's sNDA to expand the use of Xhance fluticasone propionate nasal spray for the treatment of chronic sinusitis in patients without nasal polyps and has set the PDUFA target date for completion of its review as December 16, 2023. The FDA approved Xhance for the treatment of nasal polyps in 2017. Optinose submitted … [Read more...] about FDA accepts Optinose’s sNDA for Xhance, sets PDUFA date

Orexo announced that the FDA will require the company to resubmit its NDA for OX124 intranasal dry powder naloxone due to "unexpected technical issues with the equipment used for the secondary packaging process in the outsourced supply chain for OX124." The company had announced its submission of the NDA in February 2023. According to Orexo, the agency's only request … [Read more...] about Orexo says it will have to resubmit NDA for OX124 intranasal naloxone

The FDA has granted Fast Track designation to Renovion's ARINA-1 nebulized mucolytic for the prevention of bronchiolitis obliterans syndrome in patients who have had a bilateral lung transplant, which will allow the company to take advantage of a rolling NDA submission, Renovion said. In August 2022, the company announced that it had received a Study May Proceed … [Read more...] about Renovion’s ARINA-1 inhaled mucolytic gets Fast Track designation for prevention of BOS following lung transplant

The FDA's Pulmonary-Allergy Drugs Advisory Committee (PADAC) has scheduled a meeting on May 11, 2023 to review the ARS Pharmaceuticals' NDA for Neffy intranasal epinephrine for the treatment of anaphylaxis and other Type 1 allergic reactions. The FDA accepted the NDA for review in October 2022. Public comments may be submitted up to April 27 for delivery to the … [Read more...] about FDA advisory committee meeting scheduled for Neffy epinephrine nasal spray

The FDA has approved Emergent Biosolutions' sNDA for OTC sales of Narcan naloxone nasal spray, 4 mg, for reversal of opioid overdose. Narcan was first approved for prescription use in the US in 2015. The agency accepted the sNDA for review in December 2022, and the Nonprescription Drugs and Anesthetic and Analgesic Drug Products advisory committees voted unanimously … [Read more...] about FDA approves Narcan for over-the-counter sales