Our Regulatory Approach
Pharma Two B follows 505(b)(2) regulatory pathway for the development of our products.
What is the 505(b)(2) regulatory pathway?
505(b)(2) is a US FDA drug approval pathway which represents an appealing regulatory strategy for appropriate drug products. A 505(b)(2) candidate may be a new dosage form, a previously approved drug developed for different indication, a novel combination of two active ingredients, or a route of administration or mechanism of drug delivery that is advantageous over the current one.
This pathway allows the applicant to rely, at least partially, on safety and efficacy findings of previously approved drugs, however it may require additional preclinical and clinical data to support the change from previously approved products. Additional CMC data are also required. This approach may potentially save time and money and lower the development risk.
505(b)(2) products may qualify for 3-7 years of marketing exclusivity.