FDA Publishes Product-Specific Guidelines for Generic Drug Development

The FDA published a new batch of product-specific guidelines (PSGs). PSGs provide recommendations for developing generic drugs and generating the evidence needed to support Abbreviated New Drug Application (ANDA) approval. These new guidelines will help streamline generic drug product development by the pharmaceutical industry and ANDA assessment by the 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. 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 and Metoclopramide Metered Nasal Spray with in vitro or in vivo BE options

• Meloxicam Solution for Intravenous Use, a complex injectable product with an in vitro BE option

When finalized, the guidelines 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 publishes PSGs to facilitate generic drug development by helping potential applicants efficiently allocate resources and prepare more complete submissions. 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.