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FDA to Investigate Quality and Effectiveness of Long-Acting Generic Drug Products

Feb 17, 2015

Last week, the U.S. Food and Drug Administration (FDA) announced that it is ready to spend nearly one million dollars to study the quality and effectiveness of long-acting generic drug products. According to Regulatory Affairs Professionals Society (RAPS), this includes levonorgestrel-based birth control products.

Three study proposals have been released relating to the quality of long-acting generic drugs, the FDA said on the National Institutes of Health's (NIH) website. The study proposals are titled:

  • Pharmacometric Modeling and Simulation for Long-Acting Injectable Products
  • Dissolution Methods for Long-acting Periodontal Drug Products
  • Dissolution Methods for Long-acting Levonorgestrel Intrauterine System

The FDA states in each notice that the focus is more on generic, rather than long-acting products. The findings from the study will “help establish scientific and regulatory standards for ensuring therapeutic equivalence of generic long acting injectable (LAI) products." the FDA's Center for Drug Evaluation and Research (CDER) said in its funding opportunity notice for Pharmacometric Modeling and Simulation for Long-Acting Injectable Products.

“The active pharmaceutical ingredient (API) in long acting injectable (LAI) products is usually encapsulated in microspheres (i.e., glycolide/lactide matrix) that extends the release of API into the systemic circulation, giving a relatively long apparent half-life and a unique PK profile." the agency explains. "The current BE guidance in regards to LAIs is that the generic formulations are required to be qualitatively (Q1) and quantitatively (Q2) the same as the reference-listed drug (RLD). In general, the FDA recommends in vivo single-dose, randomized, parallel BE study in healthy volunteers. However, parallel BE studies with LAI products are very challenging due to high inter-subject variability, complex PKPD profiles, study length and expenditure." The FDA intends to allocate as much as $600,000 towards this area of research in 2016.

The other two awards focus on generic birth control implants and periodontal drugs. The FDA states in the two proposals that there is a "lack of compendial or biorelevant in vitro drug release assays for long-acting [periodontal dosage forms and contraceptive intrauterine systems]". The FDA intends to spend at least $250,000 towards developing methods for periodontal drugs and $125,000 for intrauterine drug systems, RAPS reports. Mirena will be used as a reference product for the study on birth control devices. "The results from this study will help the FDA in developing recommendations to determine bioequivalence of generic long-acting … drug products," the agency stated.


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