Dexmedetomidine hydrochloride: what the FDA reviewed for dog products
8 Freedom of Information summaries from the FDA Center for Veterinary Medicine for products containing Dexmedetomidine hydrochloride, as typed records: every value below is followed by the verbatim passage it was taken from. Species as stated by each summary: Cat; Dogs and cats; dog.
Products
- DEXVETRA™ (NADA/ANADA 200-699)
- Dexdomitor® (NADA/ANADA 141-267)
- DexmedVet™ (NADA/ANADA 200-752)
- Dexmedesed® (NADA/ANADA 200-573)
- Dexmedetomidine Hydrochloride (NADA/ANADA 200-735)
- Dexmedetomidine Hydrochloride (NADA/ANADA 200-824)
Dexdomitor® NADA 141-267, Supplemental approval, August 16, 2010; sponsor Orion Corp.; species: Cat; foi_id 828; FDA PDF
Indication
Supplement adds use as a preanesthetic to general anesthesia in cats.
Dose regimen
40 mcg/kg, intramuscular (IM), single dose, given as a preanesthetic prior to induction of general anesthesia (ketamine 5 mg/kg IM or propofol IV in the field study)
The study showed that DEXDOMITOR administered at 40 mcg/kg by the intramuscular (IM) route was effective as a preanesthetic for cats.
Effectiveness
Masked, randomized, saline-controlled multicenter field study (#1987C-60-07-319) in 184 client-owned cats; 40 mcg/kg IM dexmedetomidine or saline followed by ketamine 5 mg/kg IM or propofol IV induction; short and long procedures analyzed separately; n = 116 dexmedetomidine; 68 saline; primary endpoint: Successful intubation after ketamine 5 mg/kg (ketamine arms); amount of propofol needed to attempt intubation (propofol arms); result: Intubation success with ketamine 88.2% (short) and 90.8% (long) after dexmedetomidine vs 15.8% and 5.5% after saline (P=0.0110, P=0.0201); mean propofol dose 5.65/5.16 mg/kg vs 10.80/10.56 mg/kg (47.7%/51.1% less); isoflurane requirement reduced 35% (ketamine) and 44.4% (propofol); lower post-operative pain VAS
Test animals: One hundred eighty four client-owned cats were enrolled with 116 receiving dexmedetomidine and 68 receiving saline.
Adverse reactions
| Term | Treated | Control | Quote |
|---|---|---|---|
| Emesis (ketamine induction arms) | 20 | 2 | Emesis 2 20 1 12 |
| Emesis (propofol induction arms) | 12 | 1 | Emesis 2 20 1 12 |
| Pale mucous membranes (ketamine induction arms) | 11 | n/a | Pale mucous membranes n/a 11 n/a 9 |
| Pale mucous membranes (propofol induction arms) | 9 | n/a | Pale mucous membranes n/a 11 n/a 9 |
| Decreased body temperature (ketamine induction arms) | 4 | n/a | Decreased body temperature n/a 4 n/a n/a |
| Retching (propofol induction arms) | 3 | 1 | Retching n/a 1 1 3 |
Extraction notes: Feline preanesthetic supplement. No target animal safety studies were required ('CVM did not require target animal safety studies for this supplemental approval'); TAS for cats is in the 2006 and 2007 summaries. Adverse reaction rows are from Table 11 with four columns in order: Saline/ketamine (T01, n=37), Dexmedetomidine/ketamine (T02, n=64), Saline/propofol (T03, n=31), Dexmedetomidine/propofol (T04, n=52); counts are numbers of cats. A dosage characterization study in 36 cats (40 mcg/kg IM then ketamine 5 mg/kg) reported one serious adverse reaction (severe bradycardia, apnea, cardiovascular depression) reversed with atipamezole.
Dexdomitor® NADA 141-267, Original approval, December 01, 2006; sponsor Orion Corp.; species: dog; foi_id 826; FDA PDF
Indication
Sedative and analgesic in dogs to facilitate clinical examinations, clinical procedures, minor surgical procedures and minor dental procedures; also as a preanesthetic to general anesthesia.
Dose regimen
375 mcg/m2 IV or 500 mcg/m2 IM (sedation/analgesia); 125 or 375 mcg/m2 IM (preanesthetic), Intravenous (IV) or intramuscular (IM), single dose, Dose by body surface area (mcg/kg decreases with body weight; dosing tables); fast 12 hours; rest quietly 15 minutes after injection
Sedation and Analgesia Dose: The dexmedetomidine intravenous (IV) dose is 375 mcg per square meter of body surface area. The dexmedetomidine intramuscular (IM) dose is 500 mcg per square meter of body surface area. Preanesthetic Dose: The dexmedetomidine intramuscular (IM) doses are 125 mcg/m2 or 375 mcg/m2 of body surface area.
Target-animal safety
dose multiples 0X, 1X, 3X, 5X; duration once daily on three consecutive days (IV 375/1125/1875 mcg/m2/day; IM 500/1500/2500 mcg/m2/day); animals 48 (8 groups of 3 males and 3 females).
(b) Purpose: The objective of the study was to assess the safety of DEXDOMITOR 0.5 mg/ml when administered once daily to 48 dogs equally divided into 8 groups (3 males and 3 females per group) by the intravenous (IV) route at 0, 375, 1125 or 1875 mcg/square meter of body surface area, or by the intramuscular (IM) route at 0, 500, 1500, or 2500 mcg/square meter of body surface area, on three consecutive days.
| Finding | Quote |
|---|---|
| Sedation 2-8 h post-dose at all doses, duration dose related; muscle twitches and sluggish pupillary response during sedation | Intravenous or IM dexmedetomidine induced sedation during 2 to 8 hours post-dosing on each dosing day at all three dose levels. The duration of sedation was dose related. |
| Dose-dependent bradycardia (IV: 33-45 bpm within 15 min, depressed 1.5-4 h) | The mean heart rates declined at all doses to between 33 and 45 beats/minute within 15 minutes of dosing and remained depressed through 1.5 to 4 hours following dosing. |
| QT prolongation and sporadic first/second degree AV block in all dose groups; no ventricular arrhythmias at peak effect | Dexmedetomidine caused bradycardia and prolongation of the QT interval. First and second degree atrioventricular block was noted sporadically in all dose groups. |
| Hypothermia: 3X IV group 92-95°F, normal within 8 hours | In the middle group, temperature decreased to 92-95°F, returning to normal within 8 hours. |
| Vomiting after IM dosing in 2/6 middle-dose and 1/6 high-dose dogs | Two (of 6) dogs in the middle dose group and 1 (of 6) in the high dose group vomited within minutes after administration of dexmedetomidine, immediately after IM administration. |
| Mild ALT increases at 3X and 5X within normal range | Most dogs in the 3X and 5X dose groups showed gradually increasing ALT values well within the normal range between predose values and day 3 values. |
| Conclusion: satisfactory margin of safety up to 5X IV or IM; no toxicological effects on body weight, clinical variables or pathology | DEXDOMITOR demonstrates a satisfactory margin of safety when administered IV or IM at doses as high as 5X the recommended dose. |
Effectiveness
Sedation/analgesia field study (UK and Germany, 12 investigators): randomized to 8 groups of dexmedetomidine 375 mcg/m2 IV or 500 mcg/m2 IM vs active control medetomidine (DOMITOR 750 mcg/m2 IV or 1000 mcg/m2 IM), with or without atipamezole reversal; 180-minute observation; dogs presented for minor procedures; n = 213 enrolled; 93 in statistical analysis of effectiveness; primary endpoint: Duration and quality of sedation (posture, response to noise, jaw tone, ability to perform procedure) and analgesia (pedal reflex), plus cardiorespiratory parameters, compared with medetomidine; result: DEXDOMITOR at 375 mcg/m2 IV or 500 mcg/m2 IM induced effects suitable for sedation and analgesia, similar to DOMITOR at approved doses; recovery satisfactory; a separate preanesthetic field study (192 dogs, 125 or 375 mcg/m2 IM vs saline) showed 30-61% induction-drug sparing
Protocol deviations resulted in 13 dogs being eliminated from the original 213 dogs. Half of the remaining dogs (n = 100) received a reversal agent following completion of the procedure; therefore, observations for these dogs ceased immediately following administration of the reversal agent, and they were excluded from the statistical analysis. Only results from dogs that were evaluated for the entire 180 minute observation period were statistically analyzed. Of the remaining 100 dogs, seven were from sites with fewer than four dogs. Sites with fewer than four dogs were eliminated from the statistical analysis because they did not allow for the replication of complete blocks that included treatment (dexmedetomidine or medetomidine) and administration route (IV or IM). Therefore, 93 dogs were included in the statistical analysis of effectiveness
Adverse reactions
| Term | Treated | Control | Quote |
|---|---|---|---|
| Arrhythmia, unspecified | 19 | 16 | Arrhythmia, unspecified 19 16 1st or 2nd degree heart block 0 3* |
| 1st or 2nd degree heart block (ECG recorded) | 0 | 3 | Arrhythmia, unspecified 19 16 1st or 2nd degree heart block 0 3* |
| Bradycardia | 1 | 1 | Bradycardia 1 1* Apnea 1 0 Slow onset of sedation 1 1 |
| Apnea | 1 | 0 | Bradycardia 1 1* Apnea 1 0 Slow onset of sedation 1 1 |
| Ineffectiveness (nonrecumbent) | 3 | 2 | Ineffectiveness (nonrecumbent) 3 2 Hypothermia 2 0 Prolonged recovery 1 4 |
| Prolonged recovery | 1 | 4 | Ineffectiveness (nonrecumbent) 3 2 Hypothermia 2 0 Prolonged recovery 1 4 |
Extraction notes: Original approval (99k-char summary; the parser placed the TAS studies inside the effectiveness section). Adverse reactions are from the sedation/analgesia field study Table 11, columns Dexmedetomidine Total n= 106 | Medetomidine Total n=107; 'control' here is the active control medetomidine (DOMITOR), not placebo. Four TAS studies are summarized; the recorded one is the GLP 0/1X/3X/5X IV and IM three-day study (study 00-008); a 4-week IM tolerance study (0, 10, 50, 250 mcg/kg) showed dose-related hepatocellular eosinophilic inclusions and corneal opacities at 250 mcg/kg. No numeric PK parameters are reported in the summary (dosage characterization cites published PK literature only).
Dexmedetomidine Hydrochloride NADA 200-735, Original approval, January 13, 2023; sponsor ZyVet Animal Health, Inc.; species: Dogs and cats; foi_id 13374; FDA PDF
Indication
Sedative and analgesic in dogs and cats to facilitate clinical examinations, clinical procedures, minor surgical procedures and minor dental procedures; also a preanesthetic to general anesthesia in dogs and cats.
Dose regimen
Dogs: 500 mcg/m2 IM or 375 mcg/m2 IV (sedation/analgesia); 125 or 375 mcg/m2 IM (preanesthesia). Cats: 40 mcg/kg IM, Dogs: intramuscular and intravenous; Cats: intramuscular, single injection
Dogs: Sedation and Analgesia: 500 mcg/m2 intramuscularly (IM) or 375 mcg/m2 intravenously (IV). Preanesthesia: 125 or 375 mcg/m2 IM. Cats: Sedation, Analgesia and Preanesthesia: 40 mcg/kg intramuscularly (IM).
Effectiveness
Biowaiver (no in vivo bioequivalence study); no effectiveness or target animal safety studies required for the ANADA; result: Biowaiver granted based on formulation characteristics
Based on the formulation characteristics of the generic product, ZYVET AH, Inc., was granted a biowaiver for the generic product Dexmedetomidine Hydrochloride sterile injectable solution.
Extraction notes: Sponsor ZYVET AH, Inc. Generic (ANADA) approval; bioequivalence waived on formulation characteristics (injectable solution, same active ingredient, concentration and dosage form as the RLNAD DEXDOMITOR, NADA 141-267). The summary contains no PK, target animal safety or effectiveness studies; the biowaiver statement is recorded under effectiveness for completeness.
DexmedVet™ NADA 200-752, Original approval, July 06, 2023; sponsor Cronus Pharma Specialities India Private Ltd.; species: Dogs and cats; foi_id 14234; FDA PDF
Indication
Sedative and analgesic in dogs and cats to facilitate clinical examinations, clinical procedures, minor surgical procedures and minor dental procedures; also a preanesthetic to general anesthesia in dogs and cats.
Dose regimen
Dogs: 500 mcg/m2 IM or 375 mcg/m2 IV (sedation/analgesia); 125 or 375 mcg/m2 IM (preanesthesia). Cats: 40 mcg/kg IM, Dogs: intramuscular and intravenous; Cats: intramuscular, single injection
Dogs: Sedation and Analgesia: 500 mcg/m2 intramuscularly (IM) or 375 mcg/m2 intravenously (IV). Preanesthesia: 125 or 375 mcg/m2 IM. Cats: Sedation, Analgesia and Preanesthesia: 40 mcg/kg IM.
Effectiveness
Biowaiver (no in vivo bioequivalence study); no effectiveness or target animal safety studies required for the ANADA; result: Biowaiver granted based on formulation characteristics
Based on the formulation characteristics of the generic product, Cronus Pharma Specialities India Private Ltd., was granted a biowaiver for the generic product DexmedVetTM (dexmedetomidine hydrochloride) sterile injectable solution.
Extraction notes: Sponsor Cronus Pharma Specialities India Private Ltd. Generic (ANADA) approval; bioequivalence waived on formulation characteristics (injectable solution, same active ingredient, concentration and dosage form as the RLNAD DEXDOMITOR, NADA 141-267). The summary contains no PK, target animal safety or effectiveness studies; the biowaiver statement is recorded under effectiveness for completeness.
DEXVETRA™ NADA 200-699, Original approval, March 11, 2021; sponsor Parnell Technologies Pty. Ltd.; species: Dogs and cats; foi_id 10554; FDA PDF
Indication
Sedative and analgesic in dogs and cats to facilitate clinical examinations, clinical procedures, minor surgical procedures and minor dental procedures; also a preanesthetic to general anesthesia in dogs and cats.
Dose regimen
Dogs: 500 mcg/m2 IM or 375 mcg/m2 IV (sedation/analgesia); 125 or 375 mcg/m2 IM (preanesthesia). Cats: 40 mcg/kg IM, Intramuscular (dogs and cats) and intravenous (dogs), single injection
Dogs: Sedation and Analgesia: 500 mcg/m2 intramuscularly (IM) or 375 mcg/m2 intravenously (IV). Preanesthesia: 125 or 375 mcg/m2 IM. Cats: Sedation, Analgesia and Preanesthesia: 40 mcg/kg intramuscularly (IM).
Effectiveness
Biowaiver (no in vivo bioequivalence study); no effectiveness or target animal safety studies required for the ANADA; result: Biowaiver granted based on formulation characteristics
Based on the formulation characteristics of the generic product, Akorn Operating Company LLC (dba Akorn Animal Health Inc.), was granted a biowaiver for the generic product Dexmedetomidine Hydrochloride Injection .
Extraction notes: Sponsor Akorn Operating Company LLC (dba Akorn Animal Health Inc.). Summary proprietary name is 'Dexmedetomidine Hydrochloride Injection'; the catalogue lists DEXVETRA. Generic (ANADA) approval; bioequivalence waived on formulation characteristics (injectable solution, same active ingredient, concentration and dosage form as the RLNAD DEXDOMITOR, NADA 141-267). The summary contains no PK, target animal safety or effectiveness studies; the biowaiver statement is recorded under effectiveness for completeness.
Dexmedesed® NADA 200-573, Original approval, November 04, 2014; sponsor Dechra Veterinary Products LLC; species: Dogs and cats; foi_id 1250; FDA PDF
Indication
Sedative and analgesic in dogs and cats to facilitate clinical examinations, clinical procedures, minor surgical procedures and minor dental procedures; also a preanesthetic to general anesthesia in dogs and cats.
Dose regimen
Dogs: 375 mcg/m2 IV or 500 mcg/m2 IM (sedation/analgesia); 125 or 375 mcg/m2 IM (preanesthesia). Cats: 40 mcg/kg IM, Dogs: IV or IM; Cats: IM, single injection
Dogs: for sedative and analgesic administer 375 mcg/m2 by intravenous (IV) injection or 500 mcg/m2 by intramuscular (IM) injection; for preanesthesia administer 125 or 375 mcg/m2 by IM injection. Cats: for sedation, analgesia, or preanesthesia administer 40 mcg/kg IM.
Effectiveness
Biowaiver (no in vivo bioequivalence study); no effectiveness or target animal safety studies required for the ANADA; result: Waiver granted from the requirement to demonstrate bioequivalence to DEXDOMITOR based on formulation characteristics
Based on the formulation characteristics of the generic product, Putney, Inc. was granted a waiver from the requirement to demonstrate bioequivalence for the generic product Dexmedetomidine HCl (dexmedetomidine hydrochloride) injectable solution.
Extraction notes: Sponsor Putney, Inc. Summary proprietary name is 'Dexmedetomidine HCl'; the catalogue lists the product as Dexmedesed®. Generic (ANADA) approval; bioequivalence waived on formulation characteristics (injectable solution, same active ingredient, concentration and dosage form as the RLNAD DEXDOMITOR, NADA 141-267). The summary contains no PK, target animal safety or effectiveness studies; the biowaiver statement is recorded under effectiveness for completeness.
Dexdomitor® NADA 141-267, Supplemental approval, September 07, 2007; sponsor Orion Corp.; species: Cat; foi_id 827; FDA PDF
Indication
Supplement adds a feline indication: sedative and analgesic in cats to facilitate clinical examinations, clinical procedures, minor surgical procedures and minor dental procedures.
Dose regimen
40 mcg/kg, intramuscular (IM), single dose, for sedation and analgesia to facilitate clinical procedures in cats
The study showed that DEXDOMITOR administered at 40 mcg/kg by the intramuscular (IM) route of administration was effective for sedation and analgesia in cats.
Target-animal safety
dose multiples 0X (vehicle), 1X (40 mcg/kg), 3X (120 mcg/kg), 5X (200 mcg/kg); duration 3 consecutive days of daily IM administration; animals Thirty-six (18 male; 18 female).
Test Animals: Thirty-six (18 male; 18 female), 6 to 8 months of age, healthy, Do mestic Shorthair cats.
| Finding | Quote |
|---|---|
| Corneal opacity absent in controls, incidence increased with dose; resolved by 4 h at 1X but persisted at 8 h at 3X and 5X | Corneal opacity resolved by 4 hours in the 1X group but was still present at 8 hours in the 3X and 5X groups. |
| Miosis seen only in the 5X group | Abnormalities in pupil diameter were not observed in the control group (0X) or in the 1X and 3X groups. |
| Degree and duration of sedation were dose-related | In the dexmedetomidine treated groups, the degree and duration of sedation were dose-related. |
| Dose-dependent decrease in heart rate | The mean heart rate showed significantly greater decreases as dose increased (p<0.0001) |
| Irregular rhythms (junctional escape beats, ventricular complexes) at all dose levels but no AV block | Dexmedetomidine did not induce atrioventricular block under these experimental conditions. |
| Hypothermia: 7 cats had temperatures below 86 F at hour 8 | At hour 8, hypothermic temperatures in 7 cats resulted in missing values that were known to be <86 |
| Injection-site inflammation slightly exacerbated at 3X and 5X | In the intermediate and high dose groups, a slight exacerbation was seen in the severity (minimal to moderate) of the lesion. |
Effectiveness
Masked, randomized, double-dummy, multicenter field study (MPV 03 02) in 242 client-owned cats; 40 mcg/kg IM dexmedetomidine vs active control xylazine 2.2 mg/kg IM; non-inferiority design; n = 122 dexmedetomidine; 120 xylazine; primary endpoint: Success rate (score 3 or 4) for ability to perform the procedure 30 minutes after treatment; non-inferiority margin -13%; result: Success rate 91.7% dexmedetomidine vs 87.5% xylazine; lower CI bound of difference (-4%) exceeded the -13% margin, so dexmedetomidine was non-inferior; sedation and pedal-reflex analgesia scores consistently higher than xylazine
Cats in the dexmedetomidine group (n = 122) received an intramuscular injection of dexmedetomidine and an intramuscular injection of a placebo. Cats in the xylazine group (n = 120) received an intramuscular injection of xylazine and an intramuscular injection of a placebo.
Adverse reactions
| Term | Treated | Control | Quote |
|---|---|---|---|
| Vomiting | 70 (57%) | 82 (68%) | Vomiting 70 57 82 68 |
| Urinary incontinence | 6 (5%) | 11 (9%) | Urinary incontinence 6 5 11 9 |
| Hypersalivation | 4 (3%) | 5 (4%) | Hypersalivation 4 3 5 4 |
| Involuntary defecation | 4 (3%) | 1 (≤ 1%) | Involuntary defecation 4 3 1 ≤ 1 |
| Hypothermia | 2 (2%) | 1 (≤ 1%) | Hypothermia 2 2 1 ≤ 1 |
| Arrhythmia | 1 (≤ 1%) | 2 (2%) | Arrhythmia 1 ≤ 1 2 2 |
Extraction notes: Feline supplemental approval; summary states the canine product is unchanged. Adverse reaction rows are from field-study Table 5, columns in order: DEX n, DEX %, XYL n, XYL % (DEX N=122, XYL N=120). TAS design quote says thirty-six cats but the dosing table lists 24 cats (3 male + 3 female per group x 4 groups); a separate 10X (400 mcg/kg) single-dose acute tolerance study in 6 cats is also summarized (all sedated, vomiting in 5 of 6, corneal opacity, hypothermia, no mortality). Some words in the PDF text are split by spaces (e.g. 'Do mestic'); quotes reproduce the extracted text.
Dexmedetomidine Hydrochloride NADA 200-824, Original approval, September 19, 2025; sponsor Felix Pharmaceuticals Pvt. Ltd.; species: Dogs and cats; foi_id 17446; FDA PDF
Indication
Sedative and analgesic in dogs and cats to facilitate clinical examinations, clinical procedures, minor surgical procedures and minor dental procedures; also a preanesthetic to general anesthesia in dogs and cats.
Dose regimen
Dogs: 500 mcg/m2 IM or 375 mcg/m2 IV (sedation/analgesia); 125 or 375 mcg/m2 IM (preanesthesia). Cats: 40 mcg/kg IM, Dogs: intramuscular and intravenous; Cats: intramuscular, single injection
Dogs: Sedation and Analgesia: 500 mcg/m2 intramuscularly (IM) or 375 mcg/m2 intravenously (IV). Preanesthesia: 125 or 375 mcg/m2 IM. Cats: Sedation, Analgesia and Preanesthesia: 40 mcg/kg intramuscularly (IM).
Effectiveness
Biowaiver (no in vivo bioequivalence study); no effectiveness or target animal safety studies required for the ANADA; result: Biowaiver granted based on formulation characteristics
was granted a biowaiver for the generic product Dexmedetomidine Hydrochloride 0.5 mg/mL sterile injectable solution.
Extraction notes: Generic (ANADA) approval; bioequivalence waived on formulation characteristics (injectable solution, same active ingredient, concentration and dosage form as the RLNAD DEXDOMITOR, NADA 141-267). The summary contains no PK, target animal safety or effectiveness studies; the biowaiver statement is recorded under effectiveness for completeness.
Reproduce: foi_structured_search(query="Dexmedetomidine hydrochloride") and foi_summary_get(foi_id=...) in dog-geroscience-mcp; dataset foi-summaries-dog (config structured).