Below is a summary of updates to the
<font> BioMedReports.com FDA Calendar </font> , which includes a database of 285 entries as of 7/29/09. 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
<font> BioMedReports.com </font> , 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 7/29/09, Cell Therapeutics (NASDAQ:CTIC) announced that it was notified by the European Medicines Agency (EMEA) that pixantrone is eligible to be submitted for a Marketing Authorization Application (MAA) through the EMEA's centralized procedure. The centralized review process provides for a single coordinated review for approval of pharmaceutical products that is conducted by the EMEA on behalf of all European Union member states.
The EMEA also designated pixantrone as a New Active Substance, which would be eligible for a 10-year market exclusivity period in EU member states upon approval. CTIC will request a meeting with the EMEA to discuss the submission of the MAA for pixantrone to treat aggressive non-Hodgkin's lymphoma (NHL) in the EU member states.
On 7/7/09, Cell Therapeutics (NASDAQ:CTIC) announced that the EMEA has agreed to an oral explanation in support of the OPAXIO (paclitaxel poliglumex, CT-2103) Marketing Authorization Application (MAA) in September 2009 extending the review for the Committee for Medicinal Products for Human Use (CHMP) opinion on European marketing approval until 4Q09. In April, 2008 the EMEA accepted for review the MAA for OPAXIO for first-line treatment of patients with advanced non-small cell lung cancer who are performance status 2, based on a non-inferior survival and improved side effect profile.
On 6/24/09, CTIC announced that it has completed the submission of the New Drug Application (NDA) to the FDA for pixantrone to treat relapsed or refractory, aggressive non-Hodgkin's lymphoma (NHL). CTIC requested a six-month priority review, which if granted by the Agency would result in a possible FDA decision during 4Q09. The Company is now awaiting a likely mid to late August response from the FDA to accept the NDA filing, rule on the status of the priority review request, and issue a PDUFA action date for pixantrone.
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