During drug development and/or during the review of a submission, FDA regulations may change. Changes can be made immediately or they can appear as drafts. Proposed regulations or guidances are presented in draft form to seek public comment. In any case, it is important to monitor any changes – actual or proposed, to assure the success of [...]
Archive for January, 2009
New (Draft) Guidance on Standardized Numerical Identification (SNI) for Drug Products
Published January 27th, 2009 in 505(b)(2) Process. 0 CommentsAll NDA submissions require that a draft label be included. For a 505(b)(2) NDA, where do you get the information for this label? What labeling is required? What is labeling? Well, the “label” is what is on the immediate container of the drug product and can contain printed or graphic information. “Labeling” is all other [...]
Watson’s 505(b)(2) Overactive Bladder Gel Approved by FDA
Published January 29th, 2009 in News Commentary. 0 CommentsOn 1/27/2009 Watson Pharmaceuticals announced that the FDA had approved its GELNIQUE(tm) (oxybutynin chloride) Gel 10% for the treatment of overactive bladder. The gel product supplements a transdermal patch made by Watson (Oxytrol) which has not had the marketing success one might expect, perhaps due to the acceptance of the patch form by patients. So [...]