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FDA Publishes New Product-Specific Guidances to Facilitate Generic Drug Development
Today, FDA published a new batch of draft 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 76 PSGs (32 new and 44 revised) contains:
- 64 PSGs for products with no approved ANDAs (including 27 complex products)
- 29 PSGs for complex products (7 new and 22 revised PSGs)
- PSGs for products used for treatment of non-small cell lung cancer, Parkinson’s disease, chronic myeloid leukemia, brain cancer, and other conditions
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Additional noteworthy PSGs are described below, including PSGs that were supported by GDUFA-funded research. These PSGs reference products used for treatment of chronic weight management, macular edema, asthma, chronic obstructive pulmonary disease (COPD), 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 adjunct therapy for chronic weight management in adults; tirzepatide subcutaneous solution (reference listed drug (RLD): ZEPBOUND, NDA 217806)
- New PSG for treatment of macular edema; dexamethasone intravitreal implant (RLD: OZURDEX, NDA 022315)
- New PSG for asthma; flunisolide inhalation aerosol (RLD: AEROSPAN HFA, NDA 021247)
- Multiple revised PSGs for treatment of COPD; aclidinium bromide inhalation metered powder (RLD:TUDORZA PRESSAIR, NDA 202450), aclidinium bromide; formoterol fumarate inhalation metered powder (RLD: DUAKLIR PRESSAIR, NDA 210595), budesonide inhalation metered powder (RLD: PULMICORT FLEXHALER, NDA 021949), glycopyrrolate inhalation powder (RLD: SEEBRI, NDA 207923), glycopyrrolate; indacaterol maleate inhalation metered powder (RLD: UTIBRON, NDA 207930), indacaterol maleate inhalation metered powder (RLD: ARCAPTA NEOHALER, NDA 022383), and ipratropium bromide (RLD: ATROVENT HFA, NDA 021527)
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.
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