Special points of interest
 March 17th 2015 FDA approved the release of Cholbam
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CH O LB AM (co a l B a m )
Used for the treatment of: Pediatric and adult patients with
wor ks b y d own
bile acid synthesis disorders due to single enzyme defects,
and for patients with peroxisomal disorders (including
Zellweger spectrum disorders).
Dosage Form: Oral treatment for children aged three weeks
and older
Marketing Information from Manufacturer: “This
approval underscores the agency’s commitment to making
treatments available to patients with rare diseases,” said Julie
Beitz, M.D., director of the Office of Drug Evaluation III in the
FDA’s Center for Drug Evaluation and Research (CDER).
“Prior to today’s approval, patients with these rare bile acid
synthesis disorders had no approved treatment options.”
Benefits and Concerns of the Drug: This is a unique
treatment for patients with a rare condition, many of which are
under 6 years of age. Studies show a large number of
patients treated with this medication survived greater than 3
years
Coverage Recommendations: These recommendations
are available to IPC/EvergreenRx clients from their Account
Manager or Clinical Pharmacist.
r egu la ti n g ch o le ster o l
cholic acid (Rx) - Cholbam
Class: Gastrointestinal Agents
Please contact us with any questions or comments
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