505(b)(2) PRODUCT DEVELOPMENT

A 505(b)(2) drug development project represents a streamlined regulatory strategy for many pharmaceutical products today.  The provisions of 505(b)(2) were created to avoid unnecessary duplication of studies already performed on a previously approved product.  A 505(b)(2) new drug application contains full safety and effectiveness reports on the drug product, but allows information required for NDA approval on safety and efficacy of the active ingredient to come from studies not conducted by the applicant. This can result in a much less expensive and much faster route to approval.

The advent of the 505(b)(2) legislation paved the way for many novel medicines to be developed over the last couple decades.  Examples include new routes of administration for an older drug, new dosage strengths or dosing schedules, and new indications to name a few.  Because the original drug has already been approved in some form, strength and indication, the overall risk of development in both time and money is lowered.

Amachems has experience developing 505(b)(2) products.  For example, Amachems’s ASD-002 product is an injectable form the the cardiovascular drug clopidogrel, which is only available commercially currently in oral form.  Contact us today to discuss our expertise in this field and we can partner to bring your 505(b)(2) concept product to reality.