Javelin’s analgesic receives marketing authorization approval

Javelin views the UK Dyloject approval as an attractive opportunity to inaugurate its European Dyloject franchise.

Javelin’s UK marketing authorization is the first step in securing distribution and positioning of Dyloject in the global market for pain medications including nonsteroidal anti-inflammatory drugs. Javelin intends to file additional marketing applications through the mutual recognition process in a number of EU member countries in coming months, including Germany, Europe’s largest market for prescription injectable pain medications.

Commercial launch of the product will occur upon finalization of a National Health Service list price and inclusion in local hospital formularies.

Daniel Carr, CEO of Javelin, said: “Dyloject’s UK approval is a milestone in establishing Javelin as a commercial provider of novel solutions for acute pain management. Dyloject’s high efficacy, ease of administration by rapid intravenous (IV bolus) injection, quick onset, long shelf life and favorable safety profile fulfill unmet medical needs while fitting perfectly with today’s practice of acute pain control.”