What Prurisol 505 (b) (2) designation means to CTI

What Prurisol 505 (b) (2) designation means to CTIX: (Faster approval, quicker licensing with marketing partner, $$ sooner for Kevetrin trials and more)

The 505(b)(2) approval route can be utilized for a wide range of products, especially for those that represent a limited change from a previously approved drug. The following are examples of changes to approved drugs which would be appropriate to submit as 505(b)(2) applications:
• Changes in dosage form, strength, route of administration, formulation, dosing regimen, or indication
• A new combination product where the active ingredients have been previously approved
• Change to an active ingredient (e.g., different salt, ester complex, chelate, etc)
• New molecular entity when studies have been conducted by other sponsors and published information is pertinent to the application (e.g., a pro-drug or active metabolite of an approved drug)
• Change from an Rx indication to an OTC indication
• Change to an OTC monograph drug (e.g., non-monograph indication, new dosage form)
• Drugs with naturally derived or recombinant (i.e, biological) active ingredients where additional limited clinical data is necessary to show the ingredient is the same as the ingredient in the reference drug
• Bioinequivalence for drug products where the rate and or extent of absorption exceed or are otherwise different from the standards for bioequivalence compared to a listed drug. Additional studies might be required to document the safety and efficacy at the different rate and extend of delivery.
The 505(b)(2) applications are not appropriate for products:
• That are covered under Section 505(j)
• For which the only difference is lower extent of absorption than reference drug
• For which the only difference is an unintended lower rate of absorption than reference drug

Benefits and Challenges There are important potential commercial benefits to employing a 505(b)(2) regulatory strategy. As previously stated, this approval route was designed to encourage innovation and to eliminate costly and time-consuming duplicative clinical studies. For some products, the reference drug can be relied upon for essentially all safety and efficacy information (nonclinical and clinical), with the only a small amount of new work required to establish comparability to the reference drug. The 505(b)(2) applicant may qualify for 3 or 5 years of market exclusivity, depending on the extent of the change to the previously approved drug and the type of clinical data included in the NDA. This distinguishes a 505(b)(2) from an ANDA, where exclusivity can be held for only 180 days. A 505(b)(2) application may also be eligible for orphan drug or pediatric exclusivity.