segunda-feira, dezembro 06, 2004
FDA aprova primeiro genérico antiretroviral
The product, manufactured by Barr Laboratories, Inc. of Pomona, NY will be available for use within the United States and foreign countries. It is the first approval in the United States of a generic antiretroviral product to treat HIV/AIDS.
Didanosine (ddI) is the a generic version of the already approved Videx EC Delayed-Release Capsules manufactured by Bristol Myers Squibb. It is a delayed-release capsule, taken once daily.
Office of Special Health Issues Food and Drug Administration