The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA deadline dates. The entries are updated on a daily basis as new information becomes available with a total of 104 entries through today. The FDA Calendar includes the following information: company name, ticker, decision date, and description.
The Clinical Trial Calendar includes 139 entries as of today and encompasses pending clinical trial results (with a focus on late-stage, Phase 3 trials), pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA , sNDA, sBLA filings), and pending re-submissions to the FDA for complete response rulings by the agency which require more information before an approval can be granted.
1.) MannKind Corp. ( MNKD ): Submitted NDA on 3/16/09 for FDA approval of AFRESA (insulin monomer human rDNA origin) Inhalation Powder and the AFRESA Inhaler for the treatment of adults with type 1 or type 2 diabetes mellitus for the control of hyperglycemia. The expected PDUFA decision date under a standard (10-month) review is 1/16/10 for what would be an ultra rapid-acting form of insulin (achieving peak levels within 12-14 minutes to mimic the normal physiological release of insulin in healthy individuals) that is delivered through an inhaler rather than the typical route of injection by a syringe.
2.) Sanofi-Aventis ( SNY ): Multaq (dronedarone) NDA (priority review) for atrial fibrillation (a type of irregular heartbeat) - 3/18/09 is the date for FDA Advisory Panel Meeting - original PDUFA date was 1/31/09.
Multaq should be approved for delaying symptoms of atrial fibrillation and reducing hospitalization, a U.S. drug reviewer said in a memo released on Monday. However, the company should not be allowed make claims that the drug, Multaq, decreases the risk of death, Food and Drug Administration reviewer Abraham Karkowsky said in the Feb. 17 memo prepared for an advisory panel that meets Wednesday 18-March.
3.) United Therapeutics Corp. ( UTHR ) said Monday it will likely face regulatory delays for the inhaled version (Tyvaso) of its injectable pulmonary hypertension drug Remodulin because of FDA concerns over patient instructions. The original PDUFA decision date was 4/30/09, but the company expects a possible dealy of "a few months", reflecting concerns by the agency over the instructions for using the nebulizer that delivers the drug.
4.) DURECT Corp. ( DRRX ) announced positive results from a 74 patient Phase IIb clinical trial conducted by Endo Pharma ( ENDP ) of TRANSDUR-Sufentanil, a proprietary seven day patch under development for the treatment of chronic pain. DRRX expects to follow a 505(b)2 pathway for regulatory approval, as previously discussed with the FDA. Effective 8/26/09, DRRX will receive the right to develop and commercialize TRANSDUR-Sufentanil in the U.S. and Canada from ENDP .
5.) Johnson & Johnson ( JNJ ) + Bayer (BAYRY.PK): A 5/30/09 PDUFA date is pending for a new blood thinner drug, Xarelto (Rivaroxaban), in the treatment of deep vein thrombosis and pulmonary embolism. Ahead of a Thursday 3/19/09 FDA Advisory Panel Meeting to review Xarelto, documents filed by the agency reflect concerns over increased bleeding and other potential long-term safety data (e.g. liver concerns).
6.) Cephalon ( CEPH ): Reported positive results from a Phase 2 clinical trial of Nuvigil as adjunctive therapy for treating major depressive disorder in adults with bipolar I disorder and plans to conduct Phase 3 trials for this indication. CEPH plans to launch Nuvigil, the longer-lasting isomer of modafinil (sold under brand name Provigil) during 3Q09, with a label that includes the following indications: to improve wakefulness in patients with excessive sleepiness associated with treated obstructive sleep apnea (OSA), shift work sleep disorder, also known as shift work disorder (SWD), and narcolepsy.
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