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SF Rowasa AB Rating

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PharmacyIsPhun

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I had an Rx for SF Rowasa today and the Orange Book has AB rated mesalamine products that actually contain the metabisulfite, and thus are not SF (sulfite free). I don't understand how the FDA can rate a product as an equivalent when it has the inactive ingredient that the branded product specifies that is DOES NOT have. Can anyone shed some light on why these products are AB rated?
 

ucrx

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I had an Rx for SF Rowasa today and the Orange Book has AB rated mesalamine products that actually contain the metabisulfite, and thus are not SF (sulfite free). I don't understand how the FDA can rate a product as an equivalent when it has the inactive ingredient that the branded product specifies that is DOES NOT have. Can anyone shed some light on why these products are AB rated?

As you said, it is an inactive ingredient. AB rating only refers to the active ingredient. I believe it is specifically referring to the Cmax and AUC being "close enough" (I don't remember the exact percentage) to be equivalent.
 
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