This looks to be another way in which having poor relationships at FDA may continue to affect Schering's future prospects, per Reuters:
. . . .Schering received a "complete response" letter, which outlined questions that the U.S. Food and Drug Administration identified during its review of the new drug application for OTC Zegerid.
The FDA issues complete response letters to companies when it is not ready to approve a drug. It does not publicly disclose what steps are needed to win approval. . . .
Schering-Plough is responsible for the development, manufacturing and marketing of Zegerid branded OTC products with the dosage strength of 20 mg of omeprazole for heartburn-related indications in the United States and Canada. . . .
Unfortunate.
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