Upsher-Smith had to quit shipping fluoxymesterone tablets last fall when its supplier making the API for Androxy. The problem was that Upsher-Smith is the only supplier in the U.S. for the drug, which is used to treat breast cancer in women and low testosterone in men. Now Upsher-Smith says Androxy is back.
After a 9-month hiatus, the Maple Grove, MN, company says a new supplier has been secured and approved, and shipments to wholesalers of the class III schedule drug started July 9.
"When our original API manufacturer discontinued supply, we were required to secure approval from FDA for another API source," Rusty Field, chief commercial officer for the family-owned company, said in a statement. "As the sole supplier of fluoxymesterone tablets in the U.S., Upsher-Smith made seeking this approval a priority. We are pleased that we can once again make Androxy available to physicians and their patients."
Plenty of drugs appear on the FDA Drug Shortage list even when there are a handful of manufacturers. But when there is one supplier and it runs into manufacturing issues, doctors have to look for alternative treatments while patients go without. This time the issue was resolved in a matter of months, but sometimes it can take years.
That is what happened some years back when Ben Venue, the sole supplier for Johnson & Johnson's ($JNJ) ovarian cancer drug Doxil, got into trouble with the FDA for manufacturing lapses. The drugmaker initially worked out a deal with the FDA where Ben Venue made bulk Doxil but sterile filtration and packaging were done elsewhere while its Janssen unit worked to get new manufacturers approved.
When Ben Venue parent Boehringer Ingelheim decided to close the plant, Janssen scrambled again. It leased part of the plant from the German company, brought in its own team and set up its own manufacturing. It had to get FDA approval for releases on a lot-by-lot basis while it worked to get new manufacturers in place. Earlier this year, the FDA approved Taiwan-based TTY Biopharm Company as a manufacturer of Doxil and J&J is looking for a second producer to serve the U.S. market.
- here's the Androxy announcement