Statement on Supply of Videx® (didanosine) Reduced Mass 25 mg and 50 mg Tablets
We at Bristol-Myers Squibb have a longstanding commitment to increasing access to HIV medicines in resource-limited settings, and our commitment is as steadfast as ever.
We take the concerns about the supply of Videx® (didanosine) Reduced Mass 25 mg and 50 mg Tablets very seriously and we expect that there will be no didanosine treatment interruption due to any Videx supply shortage.
To help ensure pediatric patients remain on treatment, we are working with purchasing organizations to allocate available supply of Videx to children consistent with the product’s labeling -- first and foremost to children already receiving the medicine to prevent treatment lapses.
We are also actively working with the French regulatory authorities to accelerate the review and approval of a new manufacturing site for Videx. Inspections of the new site are scheduled for August 2010. This is a positive indication that approval could occur before the end of 2010. We have already begun producing Videx at the new manufacturing site, so product can be shipped upon site approval.
In the unlikely event that a supply shortage occurs despite the efforts described above, Bristol-Myers Squibb has taken an additional step to ensure a continuous supply of didanosine to meet our current customer demand. Bristol-Myers Squibb has made a donation to the Catholic Medical Mission Board, which will purchase and distribute generic didanosine free of charge to fulfill current customer demand, in the event of a Videx supply shortage. If no supply shortage occurs, the Catholic Medical Mission Board will use the donation to support HIV awareness programs in Africa.
For more than 20 years, we at Bristol-Myers Squibb have been committed to discovering, developing and delivering medicines to treat HIV/AIDS. Helping people who need our medicines to access them is part of our commitment.
July 16, 2010