Bristol-Myers Gets Notice From FDA To Clean Up Puerto Rico Manufacturing Plant–Sale of Belatacept Drug On Hold For Compli
Posted Oct 30 2010 11:07am
Belataceptis an important new drug to help in the rejection process with organ transplants. The drug is actually made in New York but packaged in Puerto Rico. If you have ever been to Puerto Rico, there are many drug factories that have been there for years, it’s like pharma manufacturing row if you will.
Abilify and rheumatoid arthritis treatment Orencia and tablets of Coumadin blood thinner are also made at the same factory. The company is hoping to come back into compliance by the year end. BD
TRENTON, N.J. (AP) — U.S. regulators have told drugmaker Bristol–Myers Squibb Co. they won't approve an important new drug until the company fixes multiple deficiencies at its Puerto Rico manufacturing plant, the company's CEO disclosed Tuesday.
The problems were disclosed in an Aug. 30 warning letter sent to the company by the Food and Drug Administration. Among the issues raised was a complaint that the plant did not set procedures or have workers follow procedures to prevent contamination of drug products that were meant to be sterile.
Belatacept, an injected drug, is made at a factory in Syracuse, N.Y., but packaged in vials at the Manati factory, Bristol–Myers spokeswoman Jennifer Mauer said.
The factory already makes two other injected drugs, blockbuster schizophrenia treatment Abilify and rheumatoid arthritis treatment Orencia, plus tablets of Coumadin blood thinner.