FDA Approves OXYMORPHONE HYDROCHLORIDE — XLCare Pharmaceuticals, Inc.

The FDA has approved XLCare Pharmaceuticals, Inc.’s abbreviated new drug application (ANDA 210175) for oral oxyymorphone hydrochloride, injecting the pharmaceutical manufacturer into the competitive market for this potent opioid analgesic just one year ahead of a scheduled patent expiry. The approval allows the company to swiftly gain market share against branded competitors before the first critical out‑of‑patent fillers enter the generic supply chain in early 2019.