"Sabahaddin Akman, owner of the Istanbul, Turkey, firm Ozay Pharmaceuticals, has pleaded guilty to charges of smuggling misbranded and adulterated cancer treatment drugs into the United States.
Akman pleaded guilty in the U.S. District Court"...
DOSAGE AND ADMINISTRATION
The recommended dose of ERIVEDGE is 150 mg taken orally once daily until disease progression or until unacceptable toxicity [see Clinical Studies].
ERIVEDGE may be taken with or without food. Swallow capsules whole. Do not open or crush capsules.
If a dose of ERIVEDGE is missed, do not make up that dose; resume dosing with the next scheduled dose.
Dosage forms and Strengths
ERIVEDGE (vismodegib) capsules, 150 mg. The capsule has a pink opaque body and a grey opaque cap, with “150 mg” printed on the capsule body and “VISMO” printed on the capsule cap in black ink.
Storage And Handling
Each ERIVEDGE (vismodegib) capsule has a pink opaque body and a grey opaque cap with “150 mg” printed on the capsule body and “VISMO” printed on the capsule cap in black ink. ERIVEDGE capsules are available in bottles of 28 capsules (NDC 50242-140-01).
Store at room temperature 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
Manufactured by: Patheon, Inc. Mississauga, Canada. Distributed by: Genentech USA, Inc. A Member of the Roche Group 1 DNA Way South San Francisco, CA 94080-4990. Revised: 01/2012This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 2/2/2012
Additional Erivedge Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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