Gilead, Astellas infectious news

Gilead said FDA accepted the company's response to a warning letter issued last year over violations of cGMP regulations identified during an inspection of the company's San Dimas, Calif., manufacturing facility. Gilead said the issues were primarily related to the manufacturing environment for antifungal drug AmBisome liposomal amphotericin B. At the time, Gilead said the letter could impact the company's ability to supply AmBisome, cystic fibrosis drug Cayston aztreonam lysine and ophthalmic drug Macugen pegaptanib (see BioCentury, Oct. 4, 2010). ...