Products for ED and dysmenorrhea have been developed and are...

Products for ED and dysmenorrhea have been developed and are currently undergoing stability studies ahead
of submission to the TGA for approval.
above is from page 3 cut and paste....
505(b)2-type formulation development

The 505(b)(2) pathway offers pharmaceutical companies a strategic advantage by reducing the time and financial investment typically required for the conventional full NDA. This approach bypasses the need for numerous nonclinical studies and extensive safety and efficacy tests.

This pathway specifically benefits new drugs similar to already approved drugs but have slight variations in formulation or administration routes. Before the Waxman/Hatch Act, approval for such drugs depended on extensive literature-based arguments provided by the applicant to prove the safety and efficacy of the new product.

Applicants can now reference the safety and efficacy data of the original innovator drug without needing a right of reference. This is possible because the API remains unchanged, implying inherent similarities in safety and efficacy between the new and original products.

While some differences in formulation or administration might require additional clinical studies for 505(b)(2) applicants, these are typically less extensive than what’s required for original innovator drugs. In many cases, a bioequivalence study suffices to demonstrate the similarity between the two drugs, leading to FDA approval. In instances where additional clinical studies are needed, the requirements are generally less stringent.

Again, the pathway also presents an opportunity for market exclusivity ranging from 3 to 7 years.

Unlike the traditional 505(b)(1) pathway, which can take up to 15 years and cost millions or even a billion dollars, the 505(b)(2) pathway offers a faster and less expensive route to market.

Key differences in the product planning phase include:

• Leveraging existing data: Look for ways to incorporate data from the public domain and the FDA's previous findings to reduce the size, scope, timeline, and cost of development.
• Exclusivity potential: Products approved under 505(b)(2) may qualify for various types of market exclusivity:
  • Orphan drug exclusivity (7 years)
  • New chemical entity exclusivity (5 years)
  • "Other" exclusivity (3 years for a "change" if certain criteria are met)
  • Pediatric exclusivity (6 months added to existing patents/exclusivity)