Today, FDA published a new batch of product-specific guidances (PSGs). PSGs provide recommendations for developing generic drugs and generating evidence to support abbreviated new drug application (ANDA) approvals. FDA publishes PSGs to help facilitate generic drug development, streamline ANDA assessment, and support greater access to safe, effective, and high-quality treatments. Improving access to generic medicines supports the agency’s mission to advance public health, as outlined in our Drug Competition Action Plan, and accelerating the development and approval of generic drugs also advances the goals of the President’s Executive Order 14273, Lowering Drug Prices by Once Again Putting Americans First.
Today’s batch of 81 PSGs (17 new and 64 revised) contains:
- 48 PSGs for products with no approved ANDAs (including 25 complex products)
- 39 PSGs for complex products (6 new and 33 revised PSGs)
- PSGs for products used for treatment of chronic obstructive pulmonary disease (COPD), opioid overdose, type 2 diabetes mellitus, and other conditions
- Additional noteworthy PSGs are described below, including PSGs that were supported by GDUFA-funded research. These PSGs reference products used for treatment of bronchoconstriction, skin infections, ocular hypertension, and other conditions.
When finalized, the PSGs in today’s batch posting will describe the agency’s current thinking and recommendations on how to develop generic drug products that are therapeutically equivalent to specific reference listed drugs. FDA considers all comments to the public docket before finalizing PSGs.
Newly Updated – Upcoming PSGs
Today, FDA also updated the “Upcoming Product-Specific Guidances for Generic Drug Product Development” web page, which includes new and revised PSGs under development and includes the planned revision categories and brief descriptions of the revisions. As stated in the GDUFA III Commitment Letter, eligible applicants may request a PSG teleconference to obtain FDA’s feedback on the potential impact of a new or revised PSG on its development program and a subsequent PSG meeting following feedback received at the PSG teleconference. See the guidance for industry Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA for more information. The web page also provides information about the agency’s plans for issuing new or revised PSGs in the coming year for all generic drug products (complex and non-complex), along with anticipated publication dates, consistent with FDA’s GDUFA III commitments.
Noteworthy PSGs in Today’s Batch:
- New PSG for maintenance treatment of chronic obstructive pulmonary disease (COPD); ensifentrine inhalation suspension (reference listed drug (RLD): OHTUVAYRE, NDA 217389)
- New PSG for emergency treatment of known or suspected opioid overdose; naloxone hydrochloride nasal spray (RLD: REZENOPY, NDA 215487)
- Revised PSG for improved glycemic control in adults with type 2 diabetes mellitus; semaglutide oral tablet (RLD: RYBELSUS, NDA 213051)
- Revised PSG for treatment of major depressive disorder; trazodone hydrochloride extended-release oral tablet (RLD: OLEPTRO, NDA 022411)
These PSGs will help streamline generic drug development efforts for a wide-range of products. PSGs may provide alternate approaches to more burdensome clinical studies, potentially accelerating the availability of important drug products, while maintaining the necessary standards for safety and efficacy.