‘Assuming’ OTC Narcan Approval, Emergent Notes Opportunity But Forecasts Full-Year Revenue Dip
Sales of Narcan nasal spray were down 14% for the full year to $373.7m and 24% in Q4 to $91.1m, Emergent reported. It includes $290m to $310m estimate for 2023 Narcan sales in guidance for all products and services adding up to $1.1bn to $1.2bn. revenues. “We are assuming that FDA grants approval for OTC treatment of Narcan and … launching this product into the OTC market in the summer," says CEO Robert Kramer.
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After US FDA Advisors Unanimously Back First OTC Naloxone Proposal, Meeting On Second Not Needed
“Meeting is no longer needed,” agency states in announcement. The same committees’ unanimous recommendation during a meeting in February on Emergent’s sNDA for OTC sales of 4-mg naloxone nasal spray made a repeat for HRT’s NDA for 3-mg spray unnecessary.
Urgency For Approval Of OTC Naloxone In US Weighed Against Using Untested Package Labeling
All members of joint advisory panel noted urgent need to expand access to naloxone and voted yes on OTC sales of Emergent's Narcan nasal spray, but many also pointed out concerns for testing needed for DFl Facts label firm unveiled to the panel as well as to FDA officials during meeting.
OTC Naloxone In US Could Limit Access Due To Costs, Comments On Emergent Switch NDA Argue
American Society of Anesthesiologists and attorney Scott Lassman say in comments submitted to docket for meeting of FDA’s Nonprescription Drug and Anesthetic and Analgesic Drug Products they disagree with agency’s suggestion studies showing all naloxone products in all delivery formats can be used safely OTC point to all the products moving to nonprescription.