FDA publishes product-specific guidances to facilitate generic drug development Today, FDA published a new batch of product-specific guidances (PSGs). PSGs provide recommendations for developing generic drugs and generating the evidence needed to support Abbreviated New Drug Application (ANDA) approval, thereby helping to streamline generic drug product development by industry and ANDA assessment by FDA. Today's batch of 21 PSGs includes: - 13 new and 8 revised PSGs
- New PSGs for products used as treatments for diseases or conditions such as:
- Sickle Cell Disease
- Mantle Cell Lymphoma
- Tenosynovial Giant Cell Tumor
- Schizophrenia
- 16 PSGs for products with no approved ANDAs (including 6 PSGs for complex products with no approved ANDAs)
- 8 PSGs for complex products (5 new and 3 revised PSGs), several of which include in vitro bioequivalence (BE) options for assisting generic drug development. Notable new guidances for complex products include:
- Fluticasone Furoate; Umeclidinium Bromide; Vilanterol Trifenatate Powder for Inhalation (reference listed drug (RLD: TRELEGY ELLIPTA). This is the first PSG for a dry powder inhaler drug product that contains one inhaled corticosteroid active pharmaceutical ingredient (API) (Fluticasone Furoate) and two bronchodilator APIs (Umeclidinium Bromide (Long-Acting Muscarinic Antagonist) and Vilanterol Trifenatate (Long-Acting Beta2 Agonist)). It is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD) and the maintenance treatment of asthma in patients aged 18 years and older.
- Midazolam Nasal Spray (RLD: NAYZILAM) and Metoclopramide Metered Nasal Spray (RLD: GIMOTI) with in vitro or in vivo BE options
- Meloxicam Solution for Intravenous Use (RLD: ANJESO), a complex injectable product with an in vitro BE option
In today's batch posting, FDA is publishing a revision to the PSG for pentosan polysulfate sodium oral capsules (RLD: Elmiron), indicated for the relief of bladder pain or discomfort associated with interstitial cystitis (painful bladder syndrome). Pentosan polysulfate sodium oral capsule is a complex product with complex APIs. The revised PSG clarifies the API sameness evaluation and includes a Biopharmaceutics Classification System Class (BCS) 3-based biowaiver option (see guidance M9 Biopharmaceutics Classification System-Based Biowaivers). The revised PSG also includes the previously recommended option to perform a comparative clinical endpoint study to demonstrate BE. The guidance was revised to reflect FDA's current thinking and to facilitate development of a generic for this complex product. 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 docket before finalizing PSGs. FDA publishes PSGs to facilitate generic drug development by helping potential applicants efficiently allocate product development resources and prepare more complete submissions, especially for products that do not currently have approved generics. Once these generic products are developed, approved, and marketed, generic competition for these drug products could support greater access to high-quality, safe, effective, and potentially lower-cost treatments. FDA aims to ensure that policies, regulations, and scientific standards keep pace with the science of equivalence. Improving patient access to high-quality and affordable medicines supports the agency's mission to advance the public health, as outlined in our Drug Competition Action Plan. Newly Updated – Upcoming Complex PSGs Today, FDA also updated the Upcoming Product-Specific Guidances for Complex Generic Drug Product Development web page, which provides information about the Agency's plans for issuing new or revised PSGs in the coming year for complex products as defined in the GDUFA II Commitment Letter. This page is updated each time FDA publishes a new batch of PSGs. For more information, to view the guidances, or to submit comments on the PSGs, visit: | 
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