"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
Advise patients to report the following to healthcare providers:
- Rashes and reddening of skin [see ADVERSE REACTIONS]
- Itchiness [see ADVERSE REACTIONS]
- Swelling of tongue [see ADVERSE REACTIONS]
- Changes in mouth and tongue sensation [see ADVERSE REACTIONS]
- Alteration in taste [see ADVERSE REACTIONS]
- That the safety and efficacy of Kepivance have not been established in patients with non-hematologic malignancies [see INDICATIONS AND USAGE and WARNINGS AND PRECAUTIONS]
- Of the evidence of tumor growth and stimulation in cell culture and in animal models of non-hematopoietic human tumors [see WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY]
Last reviewed on RxList: 6/14/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional Kepivance 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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