FDA still claims that Amylin has mislead the regulatory body by proving incomplete information with regard to the heart effects of its diabetes drug called Byetta or Bydureon, which has been approved in January for use in diabetic patients.
(prHWY.com) June 29, 2012 - Fontana, CA -- June 29, 2012 USA(Realpharmacyrx.us): The FDA (Food and Drug Administration) has claimed in their recent interview that Amylin Pharmaceutical Company has been dishonest with regard to the clinical information pertaining to its anti-diabetic medication known as Byetta.
These claims regarding Amylin's Byetta have been said long before (in the month of January) by a top official of the agency, but the complete information along with the documents have only been posted in recent times on the official FDA site.
Mary Parks, the concerned FDA official for diabetes related treatments said that Amylin has provided wrong data with respect to its drug Byetta by holding back the cardiovascular side effects associated with it in their information documents. This happened at the time, when the regulatory body was planning for the approval of this long-acting version of the drug, which is also called as Bydureon.
She also stated that all these secret findings have been possible to crack down only after the contact of Canadian regulators to the agency. And, she also said that on asking for the accurate data related to Byetta's heart side effects by the FDA, the company instead provided some of the previous documentations.
When the regulatory body asked for the fresh study in this regard to check out the accurate findings, the company was caught up. And, this resulted in time consuming and difficult review of the drug by the FDA, as the agency reported the evaluation of the potency and safety profile of Byetta to be very important for its approval.
While, Amylin claims that all its approach regarding the approval of Byetta by the FDA has been transparent with the regulatory authorities and through the entire approval process of the drug the company has been very co-operative with the FDA by timely responding to their requests for establishment of additional information.
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