Marketed Product Types
The 505(b)(2) approval pathway can be used for any approved or unapproved compound for which there is sufficient public data and is particularly useful for those compounds that represent a limited change from an approved drug.
Ideal candidates include:
- Drugs with new indications for an approved drug
- Drugs with changes in dosage form, strength, formulation, dosing regimen or route of administration
- New combination products (i.e., drug/device, biologic/device, drug/biologic or drug/device/biologic)
- Drugs with new active ingredients (i.e., ones not previously approved in the US, but where significant information exists about the active ingredient’s safety and efficacy)
- Prodrugs of an existing drug (Read More)
- Branded generics (Read More)
- Over-the-counter (OTC) monograph drugs
- Orphan drugs (Read More)
- Drug efficacy study implementation (DESI) drugs* (Read More)
New technologies have made more drug delivery techniques and options available than ever before. Moreover, pharmaceutical developers, biotechnology companies and CMOs are partnering in unique ways to produce viable solutions. From candidate identification and CMC, to shaping regulatory and commercial approaches, Camargo is an expert in seeking out and assessing your options and will help you set a sound strategic foundation for feasible development no matter the delivery mechanism. Across all sterile and non-sterile routes of administration, count on Camargo’s expertise to guide successful development.
- Injectable: Intravenous, intrathecal, subcutaneous
- Nasal and inhalation
- Oral: Immediate release, sustained release, suspension
- Transdermal (topical): Cream, gel, patch
- Vaginal and rectal: Cream, gel, suppository
*Camargo’s customized approach to navigating the 505(b)(2) development pathway presents the opportunity to secure approval for DESI drugs. The FDA’s DESI program was enacted to evaluate the efficacy of all drug products approved and marketed on safety grounds alone between 1938 and 1962. Although these DESI-approved drugs may continue to be marketed until the administrative proceedings evaluating their effectiveness have concluded, continued marketing is permitted only if an NDA is approved for such drugs. Currently, the FDA is pursuing an Unapproved Drugs Initiative against as many as 3,000 drugs still on the market without approval. For many of these drugs still in limbo, a direct path to an NDA and possible marketing exclusivity may be obtainable.