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… Read more . . .

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… Read more . . .

The FDA recently published a new product specific draft guidance for inhaled dry powder loxapine for development of generic versions of Adasuve loxapine inhalation powder, which was approved by the agency in December 2012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

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… Read more . . .

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… Read more . . .

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… Read more . . .

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… Read more . . .

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… Read more . . .

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… Read more . . .

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… Read more . . .