"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"...
Oral poliovirus vaccine (OPV) contains live attenuated poliovirus (Sabin strain types 1, 2 and 3) and is intended for polio prophylaxis in infants 6-12 weeks of age, all unimmunized children up to 18 years of age, and high-risk adults. Adults, however, should receive the inactivated poliovirus vaccine (IPV). The attenuated virus particles in OPV are harvested from monkey kidney cell cultures and undergo an extensive purification process. OPV is administered multiple times to ensure immunity to all three types of poliovirus. Clinical studies reveal that OPV is highly effective in preventing natural poliovirus-induced neurologic sequelae. OPV received FDA approval in1963.
Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.
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