This is something I have not come across in over fifty years in the pharmacy and pharmaceutical business!  The issue is related to a drug product called Hetlioz (tasimelteon) capsules, marketed by Vanda.  The product is indicated for non‑24‑hour sleep‑wake disorder (non‑24) and nighttime sleep disturbances in Smith‑Magenis Syndrome (SMS) in children and adults.  The Teva product, however, is approved at this time only for non‑24, likely due to patent or exclusivity issues.  According to the petition, non‑24 is “a rare disorder that disproportionately affects individuals who are blind—indeed, FDA estimates it affects more than half of individuals who are totally blind.  Yet, by FDA’s unlawful approval of Teva’s ANDA, tasimelteon is now being commercially marketed without the Braille labeling that these patients have relied upon since Hetlioz®’s first approval in January 2014.”

There are instructions on the bottle that direct the product be dispensed in its original container, and there is also an instruction on the label that directs the dispenser not to cover the Braille (see label below).


The petition, which can be found here, claims that the generic by Teva, which is the only currently approved generic, “fails to satisfy the same labeling and same conditions of use requirements” and, thus, “poses grave danger to public health and patient safety.”

Based on my experience and familiarity with the FDA and having had responsibility for oversight of the OGD labeling-review process during my time as Acting Deputy Director of the OGD and before that as Director of the Division of Labeling and Program Support, as well as knowing how seriously the OGD takes its labeling responsibility, I cannot imagine that this was not discussed internally, including with the new drug review division responsible for the original NDA’s approval.  This is especially true when a label carveout is required and when a deviation in labeling is sought.  The OGD has tentatively approved two other ANDAs for this product and any adverse decision here will impact those applications prior to full approval.

The arguments raised in the petition are very interesting, albeit from the Vanda perspective.  It will likewise be interesting to see how and when the Agency responds to this petition and, if it denies the petition, its reasoning for doing so.