An Overview of 505(B)(2) NDAS
Many PDG clients have found the 505(b)(2) NDA development pathway to be a more timely and cost-effective route to market. The 505(b)(2) pathway basically involves changing an already approved product to create a new drug with either a new indication, formulation, target population or other differences requiring clinical evidence for approval. Examples (and ideal candidates) include, but are not limited to the following differences from already-approved products:
- Different strength
- Dosage form
- Route of administration
- Reformulation
- Dosing regimen
- Combination products/Substitution of an active ingredient in a combination product
- Rx-to-OTC switches
- Nonprescription product that differs from OTC monograph
- Orphan Drugs
505(b)(2) NDA Reduces Cost, Risk and Time to Market
One of the major advantages of the 505(b)(2) NDA is that sponsors may rely in part upon previous FDA findings of safety and efficacy, as well as data from the scientific literature or otherwise available in the public domain. Because approval may rely upon data previously accepted by FDA, and in most cases the active moiety has already been approved, study requirements may be of lesser scope. Therefore, costs, risk and time to market are reduced. A major incentive is the potential for 3-5 years of marketing exclusivity (7 for orphan products) depending on the extent of change to the product and clinical studies required for approval by FDA.
Path to Diversify from Competitive, Low Margin Environment of Generics
Particularly suited to generic manufacturers, the 505(b)(2) NDA pathway represents a way to diversify away from a highly competitive, low margin environment while at the same time allowing development processes that involve less preclinical and clinical studies. As with any drug development strategy the 505(b)(2) pathway requires careful consideration and planning. Determining which process may be the best fit for your drug development programs can be a complex decision. PDG will help you strategically navigate intellectual property concerns, the availability and quality of data from reference products, the scientific literature, FDA, other regulatory agencies and other sources to evaluate the various options for development and commercialization of your drug product.
Source: https://pharmdevgroup.com/505b2-ndas/
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