Citizen Petition Watch - Increased Activity Around Ditropan XL

There have been two citizen petitions (from two different companies) in the last two working days requesting that the FDA determine that Ditropan XL was not withdrawn from the market for reasons of safety and efficacy. This is a common request made when a generic company wants to submit an ANDA on a reference listed drug (RLD) that has been withdrawn from the market.

It only stands out because of the increased activity on this product that already has seven approved generics for the XL version. Maybe something is going on in the market that is worth considering.

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