The FDA has 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. PSGs also assist in streamlining generic product development and ANDA assessment. FDA publishes PSGs to help facilitate generic drug competition, supporting greater access to safe, effective, and potentially lower-cost treatments. Improving access to high-quality, affordable medicines supports the agency’s mission to advance public health, as outlined in our Drug Competition Action Plan.
Today’s batch of 38 PSGs includes:
- 22 new and 16 revised PSGs
- 34 PSGs for products with no approved ANDAs (including 19 complex products)
- 22 PSGs for complex products (8 new and 14 revised PSGs)
- PSGs for products used for treatment of intermittent (asthma (reference listed drug [RLD]: PRIMATENE MIST, NDA 205920)), (type 2 diabetes [RLD] MOUNJARO, NDA 215866), (hereditary transthyretin-mediated amyloidosis [RLD] AMVUTTRA, NDA 215515), and other conditions
- Additional noteworthy PSGs are described below, including PSGs for products used for treatments for allergic reactions including anaphylaxis, migraine, allergic rhinitis, obstructive hypertrophic cardiomyopathy, acne vulgaris, and pain relief
When finalized, the guidances 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 PSGs 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 meeting following feedback received at the teleconference. The webpage 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:
- Epinephrine (RLD: AUVI-Q, NDA 201739) - FDA published a new PSG for epinephrine auto-injector, which is indicated for the emergency treatment of allergic reactions, (Type I) including anaphylaxis. The RLD is a drug-device combination product with a novel delivery system: a pressure activated autoinjector with visual cues, audible prompts, along with an automatic needle safety system. To facilitate generic development of this novel device, the PSG includes recommendations on in vitro bioequivalence (BE) studies with supportive comparative studies for assessing device performance. This PSG also includes recommendations related to external critical design attributes and external operating principles of the RLD device constituent part that patients rely on to safely and effectively prepare and administer the product.
- Five nasal suspensions (beclomethasone dipropionate monohydrate (RLD: BECONASE AQ, NDA 019389); budesonide (RLD: RHINOCORT ALLERGY, NDA 020746); ciclesonide (RLD: OMNARIS, NDA 022004); mometasone furoate/olopatadine hydrochloride (RLD: RYALTRIS, NDA 211746); and triamcinolone acetonide (RLD: NASACORT ALLERGY 24 HOUR, NDA 020468) - FDA revised the PSGs for these five nasal suspension products to recommend two options for establishing BE and update the device-related recommendations. With these revisions, prospective applicants may utilize an in vitro BE study option if formulation sameness is established between the test and RLD, along with device similarity. As part of the in vitro BE study option, two new studies are included in addition to the traditionally recommended in vitro BE studies: drug particle size distribution and dissolution studies.
- Mavacamten (RLD: CAMZYOS, NDA 214998) - FDA published a new PSG for this product, which is indicated for the treatment of adults with symptomatic New York Heart Association class II-III obstructive hypertrophic cardiomyopathy to improve functional capacity and symptoms. Mavacamten, a new chemical entity, is approved under a Risk Evaluation and Mitigation Strategy with Elements to Assure Safe Use. Due to the notable risk of heart failure, this PSG recommends in vivo bioequivalence studies with pharmacokinetic endpoints using a lower strength of 5 mg and excluding subjects with reduced cardiac function or drug metabolism capacity.
- Clascoterone (RLD: WINLEVI, NDA 213433) - FDA published a revised PSG for this product, which contains clascoterone in a topical cream formulation. Clascoterone is an androgen receptor inhibitor indicated for the topical treatment of acne vulgaris in patients 12 years of age and older. The PSG was originally issued in November 2021 and recommended a comparative clinical endpoint BE study. The revision to the PSG includes an additional option for establishing BE using a characterization-based approach, supported by in vitro data generated by the agency.
- Lidocaine Hydrochloride (RLD: XYLOCAINE, NDA 008816) - FDA published a revised PSG for this product, which contains lidocaine in a topical jelly formulation. The drug product is administered topically for prevention and control of pain in procedures involving the male and female urethra, and as an anesthetic lubricant for intubation (oral and nasal). The revised PSG includes comprehensive recommendations for a characterization-based BE approach and aligns the recommendations within the PSG with the agency’s current scientific thinking for similarly situated topical products applied to the skin.
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