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FDA tracker: psychiatric drug shortages and approvals

What's in short supply right now, and what the FDA has approved, for the medications covered on PsychiatryRx. Every row links to the FDA's own record.

Updated September 29, 2026 Source: FDA, via openFDA Reviewed by Shariq Refai, MD, MBA, FAPA

If your medication is on this list

A shortage listing doesn't always mean you can't get it. Often one strength or one manufacturer is short while others are fine. Call your pharmacy before you run low, ask whether another strength or manufacturer is in stock, and talk to your prescriber about options. Don't stop a medication abruptly because a refill is delayed; some medications cause withdrawal or discontinuation symptoms if stopped suddenly.

Current shortages

ProductAvailabilityPresentations listedLast FDA update
Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate Tablet Limited Availability, Unavailable, Available 73 from 11 companies September 18, 2026
Clonazepam Tablet Available, Limited Availability 40 from 6 companies September 16, 2026
Flurazepam Hydrochloride Capsule Available 1 from 1 company September 15, 2026
Isocarboxazid Tablet Limited Availability 1 from 1 company August 6, 2026
Lisdexamfetamine Dimesylate Capsule Available, Limited Availability, Unavailable 89 from 13 companies September 18, 2026
Lisdexamfetamine Dimesylate Tablet, Chewable Available 18 from 3 companies September 18, 2026
Lorazepam Injection Available, Unavailable, Limited Availability 11 from 4 companies September 22, 2026
Methylphenidate Film, Extended Release Available 4 from 1 company September 2, 2026
Methylphenidate Hydrochloride Tablet, Extended Release Limited Availability, Available, Unavailable 34 from 6 companies September 18, 2026
Midazolam Hydrochloride Injection Available, Unavailable, Limited Availability 27 from 6 companies September 22, 2026

Check the FDA Drug Shortages database for the latest status of a specific product.

To be discontinued

New approvals and new indications

Original approvals and efficacy supplements, which usually add a new use, population, or dosage form, in the past 36 months.

DateProductActionFDA record
July 13, 2026LEQEMBI IQLIK (lecanemab)Efficacy supplementBLA761375
June 16, 2026REXTOVY (naloxone)Efficacy supplementNDA208969
April 30, 2026AUVELITY (dextromethorphan / bupropion)Efficacy supplementNDA215430
April 27, 2026NUPLAZID (pimavanserin)Efficacy supplementNDA210793
April 27, 2026NUPLAZID (pimavanserin)Efficacy supplementNDA207318
April 24, 2026CAPLYTA (lumateperone)Efficacy supplementNDA209500
March 20, 2026ATONCY (atomoxetine)Original approvalNDA220320
February 27, 2026DULOXETINE HYDROCHLORIDE (duloxetine)Original approvalNDA219131
February 13, 2026WAKIX (pitolisant)Efficacy supplementNDA211150
December 22, 2025MUCINEX 12HR COLD & FEVER MULTI-SYMPTOM (dextromethorphan / bupropion)Original approvalNDA217338
December 18, 2025VRAYLAR (cariprazine)Efficacy supplementNDA204370
December 18, 2025VRAYLAR (cariprazine)Efficacy supplementNDA204370
December 18, 2025VRAYLAR (cariprazine)Efficacy supplementNDA204370
December 18, 2025VRAYLAR (cariprazine)Efficacy supplementNDA204370
November 5, 2025CAPLYTA (lumateperone)Efficacy supplementNDA209500
August 29, 2025ESCITALOPRAM (escitalopram)Original approvalNDA219130
August 29, 2025LEQEMBI IQLIK (lecanemab)Original approvalBLA761375
August 25, 2025KLOXXADO (naloxone)Efficacy supplementNDA212045
July 1, 2025KISUNLA (donanemab)Efficacy supplementBLA761248
June 16, 2025ARYNTA (lisdexamfetamine)Original approvalNDA219847
May 9, 2025REXULTI (brexpiprazole)Efficacy supplementNDA205422
April 15, 2025VALTOCO (diazepam)Efficacy supplementNDA211635
March 28, 2025ABILIFY MAINTENA KIT (aripiprazole)Efficacy supplementNDA202971
March 28, 2025ABILIFY ASIMTUFII (aripiprazole)Efficacy supplementNDA217006
February 21, 2025SUBLOCADE (buprenorphine)Efficacy supplementNDA209819
January 24, 2025LEQEMBI (lecanemab)Efficacy supplementBLA761269
November 26, 2024RALDESY (trazodone)Original approvalNDA218637
September 30, 2024QUVIVIQ (daridorexant)Efficacy supplementNDA214985
September 30, 2024QUVIVIQ (daridorexant)Efficacy supplementNDA214985
September 26, 2024COBENFY (xanomeline-trospium)Original approvalNDA216158
July 26, 2024ERZOFRI (paliperidone)Original approvalNDA216352
July 22, 2024OPIPZA (aripiprazole)Original approvalNDA216655
July 2, 2024KISUNLA (donanemab)Original approvalBLA761248
June 21, 2024WAKIX (pitolisant)Efficacy supplementNDA211150
May 7, 2024REXULTI (brexpiprazole)Efficacy supplementNDA205422
April 30, 2024INGREZZA SPRINKLE (valbenazine)Original approvalNDA218390
April 19, 2024REZENOPY (naloxone)Original approvalNDA215487
April 2, 2024FANAPT (iloperidone)Efficacy supplementNDA022192

Labeling changes

An approved labeling supplement means the FDA signed off on a change to the prescribing information. That can be a new warning, updated safety data, or a wording change. Open the FDA record to see the specific letter and label.

DateProductFDA record
August 17, 2026DULOXETINE HYDROCHLORIDE (duloxetine)NDA219131
July 10, 2026XELSTRYM (dextroamphetamine)NDA215401
June 29, 2026STRATTERA (atomoxetine)NDA021411
May 7, 2026ZYPREXA RELPREVV (olanzapine)NDA022173
April 30, 2026REXULTI (brexpiprazole)NDA205422
April 30, 2026AUVELITY (dextromethorphan / bupropion)NDA215430
April 23, 2026ADDERALL XR 10 (dextroamphetamine)NDA021303
April 23, 2026MYDAYIS (dextroamphetamine)NDA022063
April 23, 2026VYVANSE (lisdexamfetamine)NDA021977
April 23, 2026VYVANSE (lisdexamfetamine)NDA208510
April 20, 2026ZURZUVAE (zuranolone)NDA217369
April 10, 2026CONCERTA (methylphenidate)NDA021121
April 9, 2026REZENOPY (naloxone)NDA215487
April 8, 2026INGREZZA SPRINKLE (valbenazine)NDA218390
March 23, 2026KETALAR (ketamine (racemic))NDA016812
March 20, 2026KETALAR (ketamine (racemic))NDA016812
March 9, 2026QUILLIVANT XR (methylphenidate)NDA202100
February 11, 2026NARCAN (naloxone)NDA208411
February 2, 2026CONCERTA (methylphenidate)NDA021121
February 2, 2026CONCERTA (methylphenidate)NDA021121
February 2, 2026CONCERTA (methylphenidate)NDA021121
January 30, 2026ZYPREXA (olanzapine)NDA021253
January 30, 2026LYBALVI (olanzapine)NDA213378
January 30, 2026ZYPREXA (olanzapine)NDA020592
January 30, 2026ZYPREXA ZYDIS (olanzapine)NDA021086
January 30, 2026ZYPREXA RELPREVV (olanzapine)NDA022173
January 28, 2026ABILIFY MAINTENA KIT (aripiprazole)NDA202971
January 16, 2026LEQEMBI (lecanemab)BLA761269
January 16, 2026RYKINDO (risperidone)NDA212849
January 9, 2026NARCAN (naloxone)NDA208411

Showing the 30 most recent of 194. The full list is in the CSV download.

Labeling changes by medication, past 36 months

Method

Shortages: every openFDA shortage entry in the Psychiatry therapeutic category, plus entries whose generic name matches a medication covered on PsychiatryRx. Approval actions: approved original applications, efficacy supplements, and labeling supplements on NDA and BLA applications (brand and biologic products) for medications covered on PsychiatryRx. Generic (ANDA) and manufacturing supplements are excluded.

Update schedule. This page refreshes automatically every week from openFDA. If a refresh returns data that fails validation, the page keeps the last good version.

Download and reuse

The tables and CSVs on this page are licensed Creative Commons Attribution 4.0 (CC BY 4.0). You can use, share, and adapt them, including commercially, as long as you credit "PsychiatryRx analysis of FDA data" and link to this page.

How to cite this page
Short
FDA tracker: psychiatric drug shortages and approvals. PsychiatryRx, 2026. https://psychiatryrx.org/data/fda-tracker/
APA
Refai, S. (2026, September 29). FDA tracker: psychiatric drug shortages and approvals. PsychiatryRx. https://psychiatryrx.org/data/fda-tracker/
MLA
Refai, Shariq. "FDA tracker: psychiatric drug shortages and approvals." PsychiatryRx, 29 Sep. 2026, psychiatryrx.org/data/fda-tracker/.

Medically reviewed by Shariq Refai, MD, MBA, FAPA. Link to this page rather than copying it; see our copyright page for reuse terms.