New drug application pathway

Many PDG clients have found the 505(b)(2) new drug application (NDA) development pathway to be a more timely and cost-effective route-to-market.

The 505(b)(2) pathway 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
  • Switching from prescription drugs (Rx) to over-the-counter (OTC)
  • 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.

As approval may rely upon data previously accepted by US Food and Drug Administration (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 three to five years of marketing exclusivity (seven 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 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 what process may be the best fit for your drug development programmes 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 commercialisation of your drug product.