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 48 PSGs (34 new and 14 revised) contains:
- 37 PSGs for products with no approved ANDAs (including 6 complex products)
- 13 PSGs for complex products (10 new and 3 revised PSGs)
- PSGs for products used for treatment of postpartum depression, Duchenne muscular dystrophy, and other conditions.
- Additional noteworthy PSGs are described below, including PSGs that were supported by GDUFA-funded research. These PSGs include reference products used for the treatment of conditions such as bronchoconstriction, asthma, chronic obstructive pulmonary disease, allergic reactions, and other conditions.
When finalized, the PSGs in today’s batch will describe the agency’s current thinking and recommendations on how to develop generic drug products that are expected to be therapeutically equivalent to specific reference listed drugs. FDA considers 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 Treatment or Prevention of Bronchoconstriction and to Reduce Risk of Exacerbations in Patients with Asthma Albuterol Sulfate; Budesonide Inhalation Metered Aerosol (Reference Listed Drug (RLD): AIRSUPRA, NDA 214070)
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New PSG for Maintenance Treatment of Chronic Obstructive Pulmonary Disease Budesonide; Formoterol Fumarate Inhalation Metered Aerosol (RLD: SYMBICORT AEROSPHERE, NDA 216579)
- New and Revised PSGs for Epinephrine
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Revised PSG for Temporary Relief of Mild Symptoms of Intermittent Asthma Epinephrine Inhalation Metered Aerosol (RLD: PRIMATENE MIST, NDA 205920)
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New PSG for Emergency Treatment of Type I Allergic Reactions Epinephrine Nasal Spray (RLD: NEFFY, NDA 214697)
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New PSG for Hypotension Associated with Septic Shock Epinephrine Intravenous Solution (RLD: ADRENALIN, NDA 215875)
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New PSGs for new dosage forms approved via Suitability Petitions Carbinoxamine Maleate Oral Disintegrating Tablet (RLD: CLISTIN, NDA 008955) Metformin Hydrochloride Oral Chewable Tablet (RLD: GLUCOPHAGE, NDA 020357)
These PSGs will streamline generic drug development efforts for a wide-range of products such as providing alternate approaches to more burdensome clinical studies potentially accelerating the availability of important drug products including more patient-friendly formulations while maintain the necessary standards for safety and efficacy.
