FDA denies Ipsen’s citizen petition for blockbuster drug Somatuline

US drug reg­u­la­tors have turned down Ipsen’s ef­fort to slow down gener­ic com­pe­ti­tion for its block­buster drug So­mat­u­line De­pot, which is used to slow the growth of some tu­mors as well as for the rare dis­ease acromegaly.

The FDA de­nied the com­pa­ny’s 2019 cit­i­zen pe­ti­tion, in which Ipsen asked the agency to set up sev­er­al re­quire­ments for com­pa­nies that want­ed to get gener­ic ver­sions of the drug ap­proved. So­mat­u­line was first ap­proved in 2007, and brought in $1.1 bil­lion in 2023 — 34% of the com­pa­ny’s sales, ac­cord­ing to its fi­nan­cial fil­ings. Rev­enue from the drug has been de­clin­ing as gener­ics have come on the mar­ket in re­cent years.

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