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FDA to reevaluate Dr. Reddy's drug
By Our Special Correspondent
HYDERABAD,
FEB. 7.
Dr. Reddy's Laboratories announced that the Food and Drug Administration (FDA) plans an expedited reevaluation of its review of the AmVazTM NDA, which was granted final approval in October. It received a communication from the FDA stating that the reevaluation was prompted by questions raised about the source of the data relied upon by the FDA in its review, and that the agency would stay the approval for AmVazTM pending expedition reevaluation.
According to a release issued by Dr. Reddy's here on Saturday, the FDA indicated that it believed that the approval of AmVazTM did not rely on any proprietary data from Pfizer's NDA.
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