Por: Business Times
Gilead Sciences Inc. received a warning letter from the Food and Drug Administration about problems at its San Dimas, Calif., manufacturing facility, the drug maker said Wednesday.
The letter could limit supplies of the anti-fungal drug AmBisome, the inhaled cystic fibrosis treatment Cayston and the injectable wet age-related macular degeneration drug Macugen outside the United States, Foster City-based Gilead (NASDAQ: GILD) said in a Securities and Exchange Commission filing.
Gilead said it believes it has addressed the FDA’s concerns about the manufacturing environment for AmBisome, quality procedures and controls and investigation procedures for the HIV-fighting drug Viread, and “a generalized concern over the effectiveness of the San Dimas quality unit in carrying out its responsibilities.”
Gilead said it is working the the agency to resolve any outstanding concerns listed in the letter, but said the FDA could withhold permission to export AmBisome to some countries outside the United States and Europe.
“We do not believe the letter will impact our ability to supply any of our solid dosage form products: Atripla, Emtriva, Hepsera, Letairis, Ranexa, Truvada or Viread,” Gilead said in the SEC filing.
The inspections were in January and February, and Gilead said it responded in March.