The FDA has released new and revised product-specific guidance covering diverse therapeutic categories to accelerate generic drug development.
The new guidance—including 40 new and 14 revised guidance—is intended to “foster drug product development, ANDA submission and approval, and ultimately provide increased access to generic drugs," noted the FDA.
Revised guidance includes several high-profile medications, including:
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Aripiprazole (suspension, extended release; intramuscular)
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Celecoxib (capsule)
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Daridorexant hydrochloride (tablet)
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Ertugliflozin (tablet)
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Verapamil hydrochloride (tablet)
For complex products approved in new drug applications on or after October 1, 2022, product specific guidance will be issued for 50% of such products within 2 years of approval and for 75% within 3 years. For non-complex drugs containing a new chemical entity, the agency commits to issuing product specific guidance for 90% of products within 2 years of approval.
To establish bioequivalence for pharmaceutically equivalent drug products, manufacturers may use various types of evidence, including in vivo or in vitro testing. The selection of methodology depends on the purpose of the study, the analytical methods available, and the nature of the drug product.
The guidance addresses products with varying complexity. While standard oral solid dosage forms may require conventional pharmacokinetic bioequivalent studies, complex delivery systems often require more advanced approaches, such as metered-dose inhalers (eg, albuterol sulfate, budesonide, epinephrine), extended-release formulations (eg, deutetrabenazine, aripiprazole), and specialized dosage forms (eg, diazepam buccal film).
The FDA advised that sponsors conducting pharmacokinetic, pharmacodynamic, bioequivalence, or bioavailability studies to support Abbreviated New Drug Applications should review current reference listed drug labeling carefully, with particular attention to boxed warnings, contraindications, warnings and precautions, and adverse reactions.
Source: FDA