|Pozen’s PA8140/PA32540 Tablets Get Another Look|
|By Dr. Amna Sheikh|
|Tuesday, 11 November 2014 10:20|
As you may know, POZEN Inc. (NASDAQ: POZN), gets another chance for a New Drug Application reevaluation after their previous NDA was not accepted due to the issues indicated at some stage in an inspection of the production facility creating an essential constituent necessary for the production of the firm's PA8140/PA32540 Tablets.The company was notified about the only deficiency as narrated above through a Complete Response Letter on April 25, 2014. However, now FDA has agreed to reevaluate another NDA being submitted by POZEN under Class 2 resubmission for acceptance of PA8140/PA32540 Tablets in U.S. jurisdiction. The new target date is set on December 30, 2014.
What are PA8140/PA32540 Tablets?
The PA8140 and PA32540 tablets are the first members of POZEN’s PA product platform. The PA product policy addresses trial integrated aspirin therapies. The main goal of this portfolio is treatment of GI ulcers and additional GI problems in contrast to consumption of plain or enteric-coated aspirin alone. PA8140 is considered as the first candidate of PA product platform and it is comprised of eighty one milligrams of aspirin and forty milligram of immediate release omeprazole combined with a proton drain inhibitor coated in pH-sensitive aspirin core.
The other candidate of PA product portfolio is PA32540. It contains about three hundred and twenty five milligrams of aspirin and forty milligrams of omeprazole combined with a proton pump inhibitor coated in pH-sensitive aspirin core just like in PA8140. These products have been recommended for oral intake once in a day time. Moreover, a caution is required for utilization for the resultant avoidance of cardiovascular ailment in people who are in danger of aspirin provoked gastric ulcers.
According to the research results, it has been recommended that both PA8140/PA32540 tablets contain above listed quantity of aspirin and omeprazole. So, these are suggested for patients who need aspirin to curtail the associated threat of death in addition to those with nonlethal stroke and those who are already suffering with transient ischemic or ischemia mental stroke as a result of fibrin platelet emboli.
Moreover, the same drug is for patients who have life threatening danger and curable MI or the patients who are suffering with unstable angina pectoris, patients with persistent established angina pectoris or the sufferers who have experienced revascularization procedures with pre existing suggestion of aspirin. The basic perspective of using these tablets is reducing the gastric ulcers onset in people susceptible for developing aspirin related gastric ulcers.
About POZEN Inc
The POZEN Inc is an undersized pharmaceutical company specialized in manufacturing new therapeutics for counterproductive medicinal needs and authorizing the produced medicines to other companies in the industry for commercialization. POZEN has always used and implemented out of box strategy that has helped then attain FDA approval for two self invented medicines. All these milestones have helped POZEN create a successful and cost effective portfolio comprised of aspirin therapies intended for facilitating the use of aspirin by reducing its gastrointestinal tract related adverse effects.