What is a 505(b)(2) Filing?

Situated between the NDA and the ANDA, a 505(b)(2) application is a type of US New Drug Application (NDA) that contains full reports of investigations of safety and effectiveness, but where at least some of the information required for approval comes from studies not conducted by or for the applicant and for which the applicant has not obtained a right of reference.

Source: U.S. FDA (www.fda.gov)

Exploring the 505(b)(2) Pathway

The 505(b)(2) application pathway was created in 1984 as part of the Hatch-Waxman Act, as it has become known, in order to rectify the scarcity of generic approvals in the U.S. at the time. [Its official name is the Drug Price Competition and Patent Term Restoration Act, which created new sections of the Federal Food, Drug and Cosmetic Act.]. 

Benefits of 505(b)(2)

  • Relatively lower risk because of previous drug approval(s)
  • Lower cost, accelerated development timeline due to requirement for fewer studies
  • May qualify for three, five or seven years of market exclusivity

Ideal 505(b)(2) candidates

  • Previously approved drugs targeting new indications
  • Drugs with changes in dosage form, strength, formulation, dosing regimen or route of administration
  • New combination products using previously approved drugs
  • Prodrugs of an existing drug
  • In some cases, drugs with new active ingredients

Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act (The “Hatch-Waxman” act) was created to simplify and speed up the approval process for drugs incorporating pharmacological agents which have already received approval. In such cases, the FDA application relies on clinical data previously submitted by others.​

The intent of the 505(b)(2) pathway was to speed up the FDA application & review process and encourage further innovation with already- approved chemical entities by eliminating the need to duplicate, previously performed work.

Using a 505(b)(2) filing, companies and organizations can reference existing data and studies. This is done in consultation with the FDA. The 505(b)(2) approval process can lower risks (e.g., clinical and regulatory) while accelerating development and commercialization.

Source: U.S. FDA (www.fda.gov)

Working on a project using the 505(b)(2) pathway?

We’ve been working with clients for years on 505(b)(2) programs. At present, we are supporting over 120 API programs utilizing the 505(b)(2) pathway.

How can we help?

  • LGM streamlines procurement and supply chain efforts for 505(b)(2) programs
  • Provide access to 200+ qualified API manufacturers globally (FDA approved to support quality & regulatory requirements throughout development process)
  • Support programs from early stage R&D all the way through commercial launch (either as primary or alternate source to mitigate risk)
  • Experienced logistics team handles all movement of material from manufacturer direct to client’s facility / drug product CDMO (shipment, import/customs, etc.)

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LGM Pharma Acquires CDMO

On July 27, 2020, LGM Pharma announced its acquisition of the formulation development and drug product contract manufacturing business of Nexgen Pharma, Inc. As a result, you will notice our new logo and visuals throughout the website. We’re working on updates to reflect the exciting, expanded CDMO capabilities and services we now can offer you.

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