Pozen resubmits drug application
07/01/2014 5:14 PM
07/01/2014 5:15 PM
Chapel Hill drugmaker Pozen said it is resubmitting its application for regulatory approval of its heart-disease treatment.
The company's shares fell 10 percent April 28 after the company announced that it had been notified by the Food and Drug Administration that its application for the drug PA couldn't be approved. The federal agency cited deficiencies at the manufacturing facility of a supplier that provides an active ingredient for the drug, a combination of coated aspirin and omeprazole, which reduces production of stomach acid.
Pozen said Tuesday it believes those problems have been addressed by the supplier.
The FDA is expected to notify Pozen whether the new application will be accepted within 14 days, Pozen said.
Physicians frequently prescribe aspirin to prevent cardiovascular disease among at-risk patients, such as those who have had heart attacks or strokes, but some patients suffer from gastric ulcers as a result. Pozen's test results showed that patients experienced fewer gastric ulcers with its drug than those who took enteric-coated aspirin.
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