Read,understand and consent to the blog's disclaimer here before proceeding
Fixed Dose combination guidelines from FDA
It appears the main things needed for approval of fixed dose combo are:
1. Data showing lack of interaction between active ingredients
2. Stability data of the combo
3. Assurance of reproducible drug release from the dosage form
Bio-availability data would be needed for FDCs to show that the combination product would produce blood levels for each of the active ingredients adequate to achieve efficacy.
V. Clinical Considerations"For many potential FDCs or co-packaged products (e.g., those in Attachment B), FDA believes adequate clinical studies confirming safety and efficacy of the combination have already been conducted, obviating the need for new clinical studies "
I think Juvisync is a relevant, recent example. It is for Diabetes control and lowering Cholesterol approved by FDA in Oct 2011. Juvisync is a combo of Sitagliptin/Junivia(>$2b/year) and Simvastatin/Zocor. Sitagliptin is a dipeptidyl peptidase 4 (DPP-4) inhibitor that enhances the body's own ability to lower elevated blood sugar and is approved for use in combination with diet and exercise to improve glycemic control in adults with type 2 diabetes. Note Sitagliptin/Junivia is still under exclusivity and the same patents also protect Juvisync.
FDA's approval of Juvisync
The Label on Juvisync
Contains separately both the indications of statin as well as Junivia (note no separate study of the combo drug is in the label)
Juvisync -Exclusivity detail - Core patent(Patent No: 6699871) claims DP-IV inhibitor, or in combination with statin also protects the FDC's exclusivity. Of-course the simvastatin patent has long expired.
Ok. Why am I digging on Combo drugs regulations,label and such ? I am doing dd on possibility of Lipitor/Crestor combo with AMR101-Omega 3 Fatty acid in 2012 and FDA's requirements, and if Lipitor's/Crestor's very broad label can be retained without extensive clinical trials on Combo. Let's remember the only other prescription Omega 3 fatty acid in the market is not approved as Combo therapy with statin in the larger (TG: 200-500mg/dl) indication , as it increase LDL.