POZEN Inc. (POZN), a pharmaceutical company focused on developing treatments for acute and chronic pain, Wednesday said the U.S. Food and Drug Administration has accepted for review the company's re submission of new drug application, or NDA, for its PA8140/PA32540 tablets.
The new user fee goal date for the NDA, which FDA indicated would be treated as a Class 2 resubmission, is December 30.
Issues raised during an audit of the manufacturing facility producing an active ingredient used in the manufacture of the products were the only deficiencies noted in the Complete Response Letter POZEN received on April 25, the company said in a statement.
If the deficiencies are not addressed by the new user fee goal date, POZEN said FDA would issue another another CRL.
Both PA8140 and PA32540 combine an immediate-release omeprazole (40 mg), a proton pump inhibitor, layered around a pH-sensitive coating of an aspirin core.
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