For an original NDA, whether it is a 505(b)(1) or 505(b)(2), there is a PDUFA fee to be paid at the time of the submission of the application or the FDA will refuse to file it. For a small business ( a company of less than 500 employees) the fee can be waived for its [...]
Archive for December, 2010
PDUFA Fee Waiver: Plan Ahead
Published December 20th, 2010 in 505(b)(2) Issues and How to:. 0 CommentsPharmacokinetic (PK) Modeling & Steady-State Simulations: Strategic Use in a 505(b)(2) Drug Development Program
Published December 13th, 2010 in 505(b)(2) Process, Formulation Issues and How to:. 0 CommentsSponsors and their investors continue to seek cost efficient ways to meet their financial milestones. Modeling can be used as a cost effective way to estimate the effect of changing an oral product from immediate release to extended release. Modeling avoids the cost of making multiple formulations and performing several multi-arm pharmacokinetic studies. The following [...]
Nuedexta® – Smart Pharmacology to Treat a Unique Disorder
Published December 11th, 2010 in 505(b)(2) Process and Formulation Issues. 0 CommentsThe FDA has approved NuedextaÃ’ (Avanir Pharmaceuticals Inc.), a drug that curbs involuntary and uncontrolled crying and laughing episodes (known as pseudobulbar affect (PBA)) that are experienced by patients with some neurological disorders. Nuedexta is the first drug to be approved to treat patients with these symptoms. Nuedexta is a combination product containing dextromethorphan hydrobromide [...]
