Halozyme and its manufacturing partner Baxter Healthcare say they've got a plan to reintroduce their withdrawn drug Hylenex. Halozyme pulled lots of the injectable drug after glass flakes were found in some vials at Baxter's manufacturing plant.
Now, the companies say the root cause of that problem has been tagged; the drug and the glass vials were incompatible, the Associated Press reports. Baxter emphasizes that its manufacturing processes weren't to blame. According to a Halozyme statement, the two companies are now prepping for a meeting at the FDA, hoping the agency will approve their proposals for getting Hylenex back on the market.
The Hylenex recall was just one of many so far this year as the FDA steps up its scrutiny of drug-manufacturing facilities.
- read the Halozyme release
- see the Genetic Engineering & Biotechnology News story
- get more from the AP