New Meaning for Extended Release
Pfizer had hoped to secure FDA approval last fall, but the agency gave conditional approval in September for Lyrica as an epilepsy treatment. At the same time, it also gave conditional clearance of the drug for treating pain associated with shingles and nerve pain associated with diabetes.
The agency also rejected Pfizer's petition that Lyrica be used as a treatment for generalized anxiety disorder. Hamm said Pfizer intends to continue pursuing FDA approval of the drug for this indication.
In December, the FDA approved the drug for the two pain indications. Monday's ruling by the FDA enables Pfizer to conduct marketing campaigns identifying the drug as approved for seizure. Doctors are permitted by law to prescribe a drug for any disease as long as the FDA approves the drug for a single disease or condition, but companies can't market the drug for unapproved uses.
Pfizer's stock was up 20 cents to $27.88 Monday afternoon.
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