Vanda Pharmaceuticals Inc. filed two petitions related
to Hetlioz (tasimelteon), to the Agency against Teva Pharmaceuticals USA, Inc.
(ANDA 211601) and Apotex Inc. (ANDA 211607). The first petition requested FDA
“Exercise its power under 21 CFR 314.150(b)(10) and/or the Agency’s inherent
authority to revoke agency approval” and “temporarily suspend Teva’s ANDA
(211601)”. Similarly, the second petition state that “FDA must temporarily
suspend Apotex’s ANDA (211607).
The
petitioner argued that the missing of “overwrite of the brand name and strength
in Braille” as well as the statements “dispense in original container” and “do
not cover Braille” on the container labeling of generic products is a violation
of the “same conditions of use” requirement found in sec. 505(j)(2)(A)(i) of
the FD & C Act and 21 CFR 314.94(a)(4).
As a result of these omissions, the petitions maintain that the ANDAs
violated the FD&C Act’s “prohibition against ‘untrue statement[s] of
material fact” The petitions also contend that the absence of braille and the
braille-related statements pose various safety concerns.
In late July, FDA denied Vanda’s petition and stated that the omission of braille from the generic container label was permissible difference under different manufacturer and special statements were not considered as “conditions of use” for Hetlioz or the generic tasimelteon 20 mg capsule products. Further, FDA does not find that either ANDA included an untrue statement of material fact related to the omission of braille or the associated instructions in their container labeling, or that not including braille or the instructions amounts to an “untrue statement of material fact.” The FDA also found that the differences in labeling do not raise any safety concerns and risk of medication errors.
Useful Links:
Link for Petition Denial Letter: https://www.regulations.gov/document/FDA-2023-P-0344-0008
Link for Container Label of Hetlioz by Vanda:
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ca4a9b63-708e-49e9-8f9b-010625443b90
Link for Container Label by Generic with Braille:
Link for Container Label by Generic without Braille:
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ce5a2fa3-ed54-422d-96c2-1821496eb32f