Mike Havrilla submits:Below is a summary of updates to the BioMedReports.com FDA Calendar, which includes a database of 284 entries as of 7/28/09. 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 2/20/09, Schering-Plough (SGP) resubmitted its Saphris (asenapine) sublingual tablets NDA in response to the FDA's complete response letter from January 2009 for the acute treatment of schizophrenia in adults and for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults as monotherapy. An FDA Advisory Panel meeting is scheduled for 7/30/09 and SGP is in the process of being acquired by Merck (MRK). In briefing documents posted online, the Agency's director of psychiatry products Thomas Laughren stated, "we generally are in agreement that the sponsor has provided adequate support to suggest effectiveness," and also that the drug's safety profile was "acceptable" and appears to be "qualitatively similar to that observed for other atypical antipsychotic drugs." On 7/28/09, Shire (SHPGY) announced that it received a Complete Response Letter (CRL) for Intuniv (guanfacine) Extended Release from the FDA. This decision comes following labeling discussions with the FDA that did not result in agreement in time to meet the PDUFA date. The FDA did not identify safety concerns regarding Intuniv in the CRL or request new clinical studies. Shire and the FDA will continue to work together to resolve the remaining labeling language over the next 4-8 weeks. Shire stated in the PR that the Company is confident on quickly reaching an agreement on the final product label and anticipates a launch during 4Q09 for Intuniv.Complete Story »