Regulatory

Lupin announced that the FDA has approved the company's ANDA for its generic of Boehringer Ingelheim's Spiriva HandiHaler tiotropium bromide inhalation powder. Health Canada approved the company's tiotropium DPI earlier this year. In the UK, the DPI was approved in August 2022. According to Lupin, the company manufactures the product at its site in Pithampur, … [Read more...] about FDA approves Lupin’s generic of Spiriva HandiHaler tiotropium bromide DPI

According to ARS Pharmaceuticals, the FDA has extend the PDUFA target date for completion of its review of ARS's NDA for Neffy epinephrine nasal spray for the treatment of allergic reactions. The agency accepted the NDA for review in October 2022 and at that time, ARS said that the PDUFA date had been set for "mid-2023." The company says that the new PDUFA date … [Read more...] about FDA extends the PDUFA target date for review of ARS’s NDA for Neffy intranasal epinephrine

China Medical System Holdings announced that the National Medical Products Administration of China has approved the company's NDA for diazepam nasal spray for the treatment of seizure clusters in epilepsy patients age 6 and older when the seizures are different for the patient's usual pattern of seizures. In the US, the diazepam nasal spray, which is marketed as … [Read more...] about NMPA approves China Medical System’s NDA for diazepam nasal spray for the treatment of seizures

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The FDA recently published a new product specific draft guidance for inhaled dry powder loxapine for development of generic versions of Adasuve loxapine inhalation powder, which was approved by the agency in December 2012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