Actavis gets final FDA approval for generic of Exalgo®
The company has received final approval from the US authority for its ANDA for a generic of Mallinckrodt's (= spin-out of Covidien) Exalgo® (hydromorphone ER tablets with strengths of 8, 12 and 16mg; see also News Flash 25.02.13). The product (with OROS™ Push-Pull osmotic delivery system; in EU branded as Jurnista® by J-C) is indicated for the management of moderate to severe pain in opioid tolerant patients who need continuous, around-the-clock opioid analgesia for an extended period of time. Exalgo® achieved annual pharma sales of approx. 200 Mio USD in 2013 (acc. IMS). A shipping of the Actavis’ product will start shortly.
The company has received final approval from the US authority for its ANDA for a generic of Mallinckrodt's (= spin-out of Covidien) Exalgo® (hydromorphone ER tablets with strengths of 8, 12 and 16mg; see also News Flash 25.02.13). The product (with OROS™ Push-Pull osmotic delivery system; in EU branded as Jurnista® by J-C) is indicated for the management of moderate to severe pain in opioid tolerant patients who need continuous, around-the-clock opioid analgesia for an extended period of time. Exalgo® achieved annual pharma sales of approx. 200 Mio USD in 2013 (acc. IMS). A shipping of the Actavis’ product will start shortly.