The 505(b)(2) pathway is an excellent avenue for emerging and growth companies to consider. In 2017, at the U.S, FDA almost 60% of all approved NDA’s were 505(b)(2)’s and the average review time for the FDA dropped to 10 months. Almost 50% of the 505(b)(2) products approved in 2017 were submitted by companies with 4 or fewer approved products in the US, and 30% of the approvals gave the company it’s only FDA-approved product.
The 505(b)(2) Pathway can:
- Expedite time to market
- Minimize development costs
- Gain 3, 5, or 7 years of market exclusivity