CHADDS FORD, Pa. — Endo Pharmaceuticals announced a short-term supply constraint of analgesic products, including Opana ER, due to the temporary shutdown of a manufacturing facility operated by Novartis Consumer Health.
"We are working collaboratively with the [Food and Drug Administration] to minimize the disruption to patients currently on therapy. Given existing inventories, the expected restart of Novartis production and our ability to shift production to other facilities we believe the supply constraints of our products should be limited," Endo COO Julie McHugh said. "With Novartis as the sole manufacturer of the current formulation of Opana ER, we plan to temporarily moderate demand of the product by asking physicians to refrain from starting new patients on Opana ER in order to minimize disruption for patients currently on the product. We currently expect this to be a short-term issue and we remain focused on working with the healthcare community to optimize the continued supply of our products for current patients."
The following products may experience a short-term supply constraint include:
Opana (oxymorphone hydrochloride) tablets CII;
Oxymorphone hydrochloride tablets CII;
Percocet (oxycodone hydrochloride and acetaminophen USP) tablets CII;
Percodan (oxycodone hydrochloride and aspirin, USP) tablets CII;
Endocet (oxycodone hydrochloride and acetaminophen USP) tablets CII;
Endodan (oxycodone hydrochloride and aspirin, USP) tablets CII;
Morphine sulfate extended-release tablets CII; and
Zydone (hydrocodone bitartrate/acetaminophen tablets, USP) CIII.
As previously reported, Novartis Consumer Health suspended production at its Lincoln, Neb.-based facility to implement manufacturing process improvements, which will address possible rare instances of errors in production.