A decade af­ter its first ap­proval, FDA ex­pands weight loss pil­l's la­bel for use in ado­les­cents

The FDA late Mon­day signed off on a sup­ple­men­tal in­di­ca­tion for bank­rupt Vivus’ Qsymia (phen­ter­mine and top­i­ra­mate) for chron­ic weight man­age­ment in obese ado­les­cents aged 12 years and old­er, de­fined as those with a body mass in­dex in the 95th per­centile or greater.

First ap­proved in 2012 for adults, Vivus strug­gled to sell Qsymia, end­ing up with less than $9 mil­lion in Q1 2020 sales, fil­ing for bank­rupt­cy lat­er that same year, and then emerg­ing from Chap­ter 11 as a whol­ly-owned sub­sidiary of Ic­ahn En­ter­pris­es LP.

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