The first table below above features an updated calendar of 78 expected FDA new product decisions while the second table highlights 92 pending clinical trial result estimates and pending FDA re-submissions or new submissions for regulatory approval. Click here for a link to my previous calendars and below is a summary of FDA and clinical trial news since my last article.
1.) Watson Pharma (WPI): WPI received FDA approval for Gelnique, which represents the first and only topical gel to treat overactive bladder. Gelnique contains the active ingredient (oxybutynin) which is already used in oral tablet (Ditropan) and skin patch (Oxytrol) formulations. Watson's gel formulation is designed to bypass liver metabolism and reduce side effects such as dry mouth, GI difficulties, and drowsiness.
2.) Savient Pharma (SVNT): SVNT announced that the pending priority review BLA for Puricase (pegloticase) with a 4/30/09 PDUFA date for treatment-failure gout will be reviewed by and FDA Advisory Panel (Arthritis Committee) on 3/5/09, which is a requirement for compounds that represent a new therapeutic class. The advisory panel will likely be focused on safety issues (cardiovascular) since Puricase has been proven effective in clinical trials.
3.) ARCA biopharma (ABIO): ABIO began trading yesterday on the Nasdaq, with a pending PDUFA date of 5/31/09 for Gencaro (bucindolol) for the treatment of chronic heart failure. ARCA also has a collaboration with LabCorp (LH) and a pending PMA for a genetic test which is designed to be used in conjunction with Gencaro. ARCA has identified genetic traits which the Company believes will predict patient responses to the drug and hopes to launch both as a personalized medicine combination to optimize treatment outcomes.
4.) Theravance (THRX): THRX submitted a NDA for Telavancin as a once-daily injectable antibiotic for the treatment of hospital-acquired pneumonia (HAP), including bacterial strains such as methicillin-resistant Staph aureus (MRSA). A 10-month standard review for the NDA results in a PDUFA date of 11/26/09.
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