FDA Calendar Updates: AZN, BMY Receive Approval for New Diabetes Drug Print E-mail
Friday, 31 July 2009 13:41

Below is a summary of updates to the BioMedReports.com FDA Calendar, which includes a database of 293 entries as of 7/31/09. The calendar was originally created by Mike Havrilla to track companies with pending new drug, biological agent, or medical device new product decisions at the FDA. With the launch of BioMedReports.com, the FDA Calendar has expanded to include the following categories: pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response letter (CRL) re-submissions to the FDA, and pending late-stage clinical trial results.

On 7/31/09, AstraZeneca (NYSE:AZN.) and Bristol-Myers (NYSE:BMY) received FDA approval for a new diabetes drug called Onglyza. The Agency will require the companies to conduct a post-approval study to evaluate the drug's cardiovascular safety in higher-risk patients, but Onglyza was not linked to increased heart problems in low-risk diabetics according to the FDA.

The following is the previous FDA Calendar entry for Onglyza: BMY and AZN have a pending NDA for Onglyza (saxagliptin oral tablets), which is a dipeptidyl peptidase-4 (DPP-4) enzyme inhibitor for Type 2 Diabetes. On 4/1/09, the FDA panel voted 10 to 2 that the clinical data for the drug rule out the risk that the drug hastens heart attack, stroke and other problems. On 4/23/09, the FDA extended the PDUFA decision date by three months to 7/30/09.

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