Why Couldn’t You Have Told Me Sooner?
A Modest Request
Back on November 23, 2005, Camargo Pharmaceutical Services filed a Citizen Petition with the FDA (2005P-0329). Camargo asked FDA to approve an ANDA filing for a proposed new product: meloxicam orally disintegrating tablets, 7.5mg and 15mg. This type of request, or suitability petition, is common. Citing an approved product (Mobic®(meloxicam) tablets), the request sought a change to an ODT formulation. FDA typically approves suitability petitions just like this one.
16 Years Later…
On November 23, 2021 — 16 years to the day after Camargo filed its petition — FDA issued its response. When receiving its response, did the folks at Camargo even remember having filed it?
The Bad News, part 1
In the response, FDA denied the request. It noted that there was already an approved product for meloxicam orally disintegrating tablets, 7.5mg and 15mg. Because there was an approved product, the suitability petition was not necessary.
What FDA did not mention was that it had approved the meloxicam ODT product (NDA 211210) on October 19, 2018, thirteen years after Camargo had filed its petition.
The Bad News, part 2
Even though FDA denied the petition, in theory, Camargo could still submit an ANDA for the product, using the approved product as a reference list drug. But not in this case. FDA delivered the second bit of bad news: the approved meloxicam ODT product (NDA 211210) was discontinued and no longer on the market. Moreover, FDA had not yet determined if the product had been discontinued for reasons of safety or efficacy.
The Glimmer of Hope
In spite of all this bad news, Camargo has a glimmer of hope. It can submit a petition asking FDA to make a determination that the discontinued product was not removed for reasons of safety or efficacy, and if so, then submit its ANDA. Just not too sure how long it might take.