Regulatory

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 . . .

The FDA has approved Pfizer’s Zavzpret zavegepant (BHV-3500) calcitonin gene-related peptide (CGRP) receptor antagonist nasal spray for the treatment of migraine. Pfizer said that it expects to launch Zavzpret in July 2023. The FDA accepted… Read more . . .

The FDA has approved Amphastar Pharmaceuticals’ NDA for 4 mg intranasal naloxone for the treatment of opioid overdose. According to the company, the nasal spray is delivered via a proprietary delivery device. A previous Amphastar… Read more . . .

According to Amneal Pharmaceuticals, the FDA has accepted the company’s ANDA for a generic version of Narcan naloxone nasal spray, 4 mg, for the treatment of opioid overdose. Amneal generics Chief Commercial Officer Andy Boyer… Read more . . .