July 24, 2012 USA: The unpredictable decision of the FDA (Food and Drug Administration) to temporarily hold the approval of an aspirin combo medication manufactured by Pozen has shocked the drug company as well as its investors, thereby causing a sudden downfall of around 16% in the investor shares of the company.
The erratic decision of the FDA to block the approval of the safe and effective aspirin combination has raised a lot of eyeballs in the pharma world. The pharmaceutical company in order to clear the way of its combo aspirin drug from the FDA has to carry out a new and fresh in vivo bioequivalence clinical research study.
The drug is currently code named as PA32540, which contains immediate-release omiprazole medication in conjugation with a 325 mg concentration of the delayed-release aspirin drug. This combination drug of aspirin has been developed with the aim of preventing ulcers in individuals belonging to high-risk of cardiovascular complications.
The biopharmaceutical company has announced within three months of its successful top line and positive phase III clinical trial data on the combo drug PA32540, that the drug regulators were not convinced with the early stage study pertaining to the drug’s bioequivalence profile.
The FDA had issues with the bioequivalence of the combo PA32540 drug to the 325 mg enteric coated (EC) aspirin that was demonstrated depending upon the data available to the regulatory authority at that time.
It also notified the drug company for the improvement of combination product with aspirin of 81mg strength, thereby carrying out an in vivo bioequivalence research study for further clarity of the drug’s potency.
John R. Plachetka, CEO of the combo aspirin Drug Company claimed that their next step will be the improvement in the drug and carrying bioequivalence study and follow the points led down by the FDA.
Realpharmacyrx.us
4th lane, Fontana, California, USA-92337
http://www.realpharmacyrx.us/