ARTICLE | Clinical News

Macugen pegaptanib regulatory update

October 4, 2010 7:00 AM UTC

Gilead received a warning letter from FDA related to violations of cGMP regulations identified during an inspection of the company's San Dimas, Calif. manufacturing facility earlier this year. The letter includes deficiencies in the manufacturing of its antifungal drug AmBisome liposomal amphotericin B, including control systems and monitoring, procedures to prevent microbiological contamination and preventative cleaning and equipment maintenance. The letter also cites concerns over quality procedures and controls and investigation procedures related to manufacturing of its HIV and HBV drug Viread tenofovir. Gilead said the letter could impact the company's ability to supply AmBisome, cystic fibrosis drug Cayston aztreonam lysine and ophthalmic drug Macugen pegaptanib. In August, Gilead said FDA "may be considering" issuing a warning letter for the plant (see BioCentury, Aug. 16). ...