Replies to post #13139 on ANI Pharmaceuticals (ANIP)

[Just the facts maam]

I believe it relates to a labelling change for Mallinkrodt's Acthar Gel

labelling change

[rgshredder]

I saw that, too, but the nda is under Mallinckrodt. There isn't any mention of the generic formulation or AniP which seems odd? The manufacturer's label was also updated (presumably today) with a date of 10/21 to include these changes:

RECENT MAJOR CHANGES---------------------------
Warnings and Precautions, Immunogenicity Potential (5.10) 10/2021
(Immunogenicity Potential: Neutralizing antibodies with chronic administration may lead to a loss of endogenous ACTH activity)

Warnings and Precautions, Use in Pregnancy (5.14) - removal 10/2021

The dose per this updated label is: 5 mL multi-dose vial containing 80 USP units per mL. Which I believe is both trade and generic formulation dosing, but JTFM, please correct me if I'm wrong.

The fact there's literally zero news on the subject available makes me wonder if Mallinckrodt adjusted the label to differentiate trade vs generic even more.
-RG

[big bambino]

Anip: If it was discontinued, wouldn't the have been before Anip purchased?