Posted 06 January 2012
By Alexander Gaffney
The US Food and Drug Administration (FDA) is warning generics manufacturers with pending Abbreviated New Drug Applications (ANDAs) that their products must adhere to the Reference Listed Drugs' (RLD) tablet size, writes Kurt Karst at FDA Law Blog.
The Office of Generic Drugs (OGD) wrote to several manufacturers that the non-uniform, larger tablets represented choking hazards, efficacy issues due to patient inability or unwillingness to swallow the tablet, and the potential for esophageal pain as a result of increased transit time when swallowing.
FDA has not, notes Karst, issued any sort of formal guidance regarding the acceptable tolerances between tablet sizes. This could leave some generics manufacturers in a minor state of confusion, and faced with the prospect of having to reconfigure production lines or tablet formulations before their ANDAs are approved.
OGD is purportedly looking to issue draft guidance on the issue in the near future.