did fluvoxamine get fda approval for ocd in 1994?
“Fluvoxamine received FDA approval for OCD in 1994.”
a host said on Psychopharmacology and Psychiatry Updates, 2026-10-03, at 01:27. hear it in context →
the episode: SSRI Dosing for OCD: Beyond FDA Guidelines (at 01:27). we link the show's own page; we do not re-host audio.
first, the part that holds
the host has it right: the FDA first approved fluvoxamine on december 5, 1994, and the indication it was approved for, then and now, is obsessive-compulsive disorder.
what we found when we went and looked
we went to the FDA's own approval database. the original new drug application for fluvoxamine maleate tablets (NDA 020243) shows an original approval date of december 5, 1994, classed as a new molecular entity under standard review. the current FDA-hosted label says "initial U.S. approval: 1994" and lists one indication only, obsessions and compulsions in obsessive-compulsive disorder. both the year and the indication check out. one detail worth knowing: the label now covers children and teens aged 8-17, and the FDA record shows an efficacy supplement for a "new patient population" approved in march 1997, so the 1994 date is the adult approval, not the pediatric one.
assertion by assertion
| assertion | verdict | what the record says |
|---|---|---|
| the FDA approved fluvoxamine in 1994 | confirmed | drugs@FDA lists NDA 020243 (fluvoxamine maleate tablets) with an original approval of december 5, 1994, type 1 new molecular entity, standard review. the current label carries the line "initial U.S. approval: 1994". limitation: the database gives the date and review type, not the full approval letter text. [1][2] |
| the approval was for obsessive-compulsive disorder | confirmed | the FDA-hosted label lists one indication: "treatment of obsessions and compulsions in patients with obsessive compulsive disorder (OCD), as defined in DSM-III-R or DSM-IV." an NIH bookshelf clinical review says the 1994 approval was for OCD. limitation: we read the current label, not the 1994 label. but OCD is the only indication the drug has ever had in the US, and no later efficacy supplement in the FDA record adds a different disorder. [1][2][3] |
| the 1994 approval included children and adolescents (a common framing, not said by the host) | misattributed | the current label covers ages 8-17, and the NIH review folds that into the 1994 approval. the FDA record shows a separate efficacy supplement, "new patient population", approved march 25, 1997. that fits pediatric use being added later, but the database page does not name the population, so this part is our inference from the record. [1][2][3] |
| fluvoxamine is FDA-approved for depression (a popular assumption, not said by the host) | false | the label lists no depression indication. the NIH review says that, unlike several other SSRIs, fluvoxamine is not FDA-approved for major depressive disorder and is sometimes prescribed for it off-label. [2][3] |
both directions
for the speaker: the FDA's approval database gives an original approval date of december 5, 1994 for the fluvoxamine tablet application, as a new molecular entity. the FDA-hosted label repeats "initial U.S. approval: 1994" and names obsessive-compulsive disorder as the only indication. an NIH bookshelf review says the same: approved in 1994 for OCD.
against: nothing in the record contradicts the host's sentence. the only gap is one of scope. on its own, "approved for OCD in 1994" could be read as covering every patient group on today's label. the record shows a march 1997 efficacy supplement for a new patient population, which most likely added the 8-17 age range. the NIH review folds pediatric use into the 1994 date, and that is less precise than the FDA record.
what this cannot say
we did not read the 1994 approval letter or the original 1994 label, only the drugs@FDA application history and a current FDA-hosted label. so our claim that the original indication was OCD rests on two things: the current label lists only OCD, and no later efficacy supplement adds another disorder. the drugs@FDA page names the 1997 supplement only as "efficacy, new patient population". linking it to the pediatric age range is our inference. the extended-release capsule is a separate, later application, and we did not check it.
sources, each one fetched and read
- U.S. Food and Drug Administration, Drugs@FDA, NDA 020243, fluvoxamine maleate tablets, application history What we read there: original approval december 5, 1994, type 1 new molecular entity, standard review. SUPPL-6 approved march 25, 1997, efficacy, new patient population. SUPPL-21 approved september 28, 2000, efficacy, new dosing regimen. Fetched 2026-10-14 (HTTP 200). https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020243
- U.S. Food and Drug Administration, structured product label, fluvoxamine maleate tablets, prescribing information (accessdata.fda.gov SPL) What we read there: "Initial U.S. Approval: 1994." indicated "for the treatment of obsessions and compulsions in patients with obsessive compulsive disorder (OCD), as defined in DSM-III-R or DSM-IV." pediatric efficacy in ages 8-17. no depression indication. Fetched 2026-10-14 (HTTP 200). https://www.accessdata.fda.gov/spl/data/ba969f43-485a-4ad8-acb1-7cabdd860df8/ba969f43-485a-4ad8-acb1-7cabdd860df8.xml
- Fluvoxamine. StatPearls, NCBI Bookshelf, National Library of Medicine, NBK619811 What we read there: "The US Food and Drug Administration (FDA) approved fluvoxamine in 1994 for the treatment of obsessive-compulsive disorder (OCD) in adult and pediatric patients aged 8 or older." also: "fluvoxamine is not FDA-approved for the treatment of major depressive disorder." Fetched 2026-10-14 (HTTP 200). https://www.ncbi.nlm.nih.gov/sites/books/NBK619811/
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