"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"...
(Generic versions may still be available.)
Metrodin® (urofollitropin for injection) is contraindicated in women who exhibit:
1. High levels of FSH indicating primary ovarian failure.
4. The presence of any cause of infertility other than anovulation, as stated in the Indications unless they are candidates for Assisted Reproductive Technologies.
5. Abnormal bleeding of undetermined origin (see Selection of Patients).
6. Ovarian cysts or enlargement of undetermined origin.
7. Prior hypersensitivity to urofollitropin.
Metrodin® (urofollitropin for injection) is also contraindicated in women who are pregnant and may cause fetal harm when administered to a pregnant woman. There are limited human data on the effects of Metrodin® (urofollitropin for injection) when administered during pregnancy.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 12/8/2004
Additional Metrodin 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.
Find out what women really need.