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FDA publishes new product-specific guidances to facilitate generic drug development
Today, FDA published a new batch of draft 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 71 PSGs (23 New and 48 Revised) contains:
- 54 PSGs for products with no approved ANDAs (including 25 complex products)
- 32 PSGs for complex products (6 new and 26 revised PSGs)
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PSGs for products such as:
- The first FDA-approved parathyroid hormone replacement therapy for hypoparathyroidism
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The first telomerase inhibitor approved representing a new therapeutic option for adults with low- to intermediate-1 risk myelodysplastic syndromes (MDS) with transfusion-dependent anemia
- Treatment of IgA nephropathy (IgAN) to reduce proteinuria and slow progression of kidney disease, representing a new therapeutic approach targeting endothelin-mediated kidney injury
- Treatment of hemophilia A or hemophilia B for routine prophylaxis to prevent bleeding or reduce the frequency of bleeding episodes
- Additional noteworthy PSGs are described below, including PSGs supported by GDUFA-funded research.
When finalized, the PSGs 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 and revised PSGs under development and includes the planned revision categories and brief descriptions of the revisions.
Noteworthy PSGs in today’s batch supported by GDUFA-funded research:
- New PSG for dexamethasone ophthalmic insert (DEXTENZA, NDA 208742) for the treatment of ocular inflammation and pain as well as treatment of ocular itching. The guidance provides a bioequivalence (BE) approach centered on an in vitro BE study, complemented by robust comparative physicochemical characterization.
- Revised PSG for buprenorphine extended-release solution for subcutaneous use (SUBLOCADE, NDA 209819) indicated for the treatment of opioid use disorder. This revised PSG adds a new in vitro BE option based on comparative in vitro drug release testing (IVRT) combined with comprehensive physicochemical and polymer characterization studies, eliminating the need for conducting lengthy pharmacokinetic (PK) BE studies in patients with opioid use disorder.
- Revised PSGs for 17 metered-dose inhaler (MDI) drug products to remove spray pattern, plume geometry, and priming/repriming studies as in vitro BE studies for MDI drug products and include an optional BE approach to conduct PK BE study with pAUC assessments in lieu of a charcoal block PK BE study. The revised PSGs include: QVAR, NDA 207921; AIRSUPRA, NDA 214070; FLOVENT, NDA 021433; and SYMBICORT AEROSPHERE, NDA 216579.
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