On August 18, FDA denied Valeant Pharmaceutical's request that FDA prevent generic applications from referencing its first-generation diazepam rectal gel product. The first-generation product contained diazepam gel in fixed-dose syringes; however, Valeant subsequently developed a product using a dial mechanism to accommodate a varying amount of gel (marketed as Diastat® AcuDial™). Valeant coordinated the introduction of the AcuDial™ product with the withdrawal of the fixed-dose product. While at least one generic manufacturer hoped to reference the first-generation product, Valeant, in turn, petitioned the FDA to prevent any such approvals.
FDA determined that generic manufacturers could properly reference the first-generation product. While FDA acknowledged that it counseled Valeant to avoid overlap between the marketing of first- and second- generation products, FDA maintained that it did not force Valeant to withdraw the fixed-dose product. FDA also determined that the concerns motivating the extensive educational effort at the introduction of the AcuDial™ product would not be necessary now because patients, pharmacies and prescribers were familiar with the AcuDial™ product, having used it for five years. Finally, while Valeant argued that generic manufacturers would have to elaborately supplement the fixed-dose prescribing information (ANDA filings only allow very minimal revisions to generic prescribing information.), FDA found that such changes would be unnecessary given the simple fixed-dose delivery mechanism and because Valeant failed to present any evidence that confusion would occur.
Therefore, FDA determined that the fixed-dose product was not withdrawn for reasons relating to safety or effectiveness and that generic applicants could reference such a product.