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Below is a summary of updates to the BioMedReports.com FDA Calendar, which includes a database of over 200 entries. 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 14/11/08, Nephros (OTC:NEPH) submitted a 510(k) application to the FDA for approval of its HDF products for ESRD in the U.S. market. Following its review of the application, the FDA requested additional information, and Nephros replied to the Agency on 13/03/09. Per FDA guidelines, the FDA has 90 days to review the additional information provided by the Company, but a response from the Agency is still pending for the OLpur H2H Hemodiafiltration (HDF) Module and OLpur MD 220 Hemodiafilter.
On 07/10/08, Nephros filed a 510(k) application for approval to market its Dual Stage Ultra-filter (DSU filters) to dialysis clinics for in-line purification of dialysate water. On 01/07/09, Nephros received approval of the DSU to be used to filter biological contaminants from water and bicarbonate concentrate used in hemodialysis procedures.
On July 2, 2009 Discovery Laboratories, Inc. (Nasdaq:DSCO) announced after receipt of written minutes from the United States Food and Drug Administration, the results of its June 2, 2009 meeting with the FDA. This meeting followed the FDA's April 17 Complete Response Letter for Surfaxin(r) (lucinactant) for the prevention of Respiratory Distress Syndrome (RDS) in premature infants and was convened to discuss resolution of the remaining primary issue necessary for marketing approval of Surfaxin. The meeting focused on the Surfaxin fetal rabbit biological activity test (BAT, a quality control stability and release test), specifically whether data that had been previously submitted to the FDA and generated using both the BAT and a well-established preterm lamb model of RDS adequately supports the comparability of Surfaxin clinical drug product to commercial drug product, and whether the BAT can adequately distinguish change in Surfaxin biological activity over time.
Sanofi-aventis (NYSE: SNY | Quote | Chart | News | PowerRating) announced on Juy 2, 2009 that the U.S. Food and Drug Administration (FDA) has approved Multaq (dronedarone) 400 mg Tablets. Patients with atrial fibrillation (AF) or atrial flutter (AFL) soon will have a new treatment option to help improve current management of their disease. Multaq is the first drug approved in the United States that has shown a clinical benefit to reduce cardiovascular hospitalization in patients with AF/AFL.
Cytori Therapeutics, Inc. (CYTX) reported on July 2, 2009 financial results for the year ended December 31, 2008, provides a review of its progress in 2008 and outlines 2009 business objectives and Clinical Trial Updates.
Biotech investors interested in seeing the complete database of clinical trials and upcoming FDA decisions can access that information here:
http://biomedreports.com/fda-calendar.html
Disclosure: No positions.
About BiomedReports.Com
BioMedReports.com is a news portal covering the biomedical news and financial sector. It features its own blog, discussion forum, stock research reports, news feeds, videos, press release capability, stock commentaries, and other unique content - including FDA and Clinical Trial Calendars plus a database that includes about 1,000 stocks and exchange-traded funds from the healthcare sector which are organized into various new healthcare stock indexes.
For more biomedical sector and investment news, go to www.BioMedReports.com
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