Respuestas rápidas
- ¿Para qué se usa Sapropterin dihydrochloride?
- La etiqueta aprobada por la FDA (Kuvan, BioMarin Pharmaceutical Inc., 26 de agosto de 2024) dice, en inglés: “KUVAN ® is indicated to reduce blood phenylalanine (Phe) levels in adult and pediatric patients one month of age and older with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin- (BH4-) responsive Phenylketonuria (PKU). KUVAN is to be used in conjunction with a Phe-restricted diet. …” Esta página no es un consejo médico. Hable con su médico o farmacéutico antes de empezar, dejar o cambiar cualquier medicamento.
- ¿Cuáles son los efectos secundarios de Sapropterin dihydrochloride?
- La sección «Adverse Reactions» (reacciones adversas) de la etiqueta de la FDA (Kuvan, BioMarin Pharmaceutical Inc., 26 de agosto de 2024) comienza así, en inglés: «Most common adverse reactions (≥4%) are: headache, rhinorrhea, pharyngolaryngeal pain, diarrhea, vomiting, cough, and nasal congestion.» … Esta página no es un consejo médico. Hable con su médico o farmacéutico antes de empezar, dejar o cambiar cualquier medicamento.
- ¿Qué interacciones tiene Sapropterin dihydrochloride?
- La sección «Drug Interactions» (interacciones) de la etiqueta de la FDA (Kuvan, BioMarin Pharmaceutical Inc., 26 de agosto de 2024) comienza así, en inglés: «Table 4 includes drugs with clinically important drug interactions when administered with sapropterin dihydrochloride and instructions for preventing or managing them. Table 4: Clinically Relevant Drug Interactions Levodopa Clinical Impact Sapropterin dihydrochloride may increase the availability of tyrosine, a precursor of levodopa.» … Esta página no es un consejo médico. Hable con su médico o farmacéutico antes de empezar, dejar o cambiar cualquier medicamento.
- ¿Sapropterin dihydrochloride tiene una advertencia en recuadro?
- No. Ninguna de las 16 etiquetas de la FDA que encontramos para este medicamento tiene advertencia en recuadro.
- ¿Hay escasez de Sapropterin dihydrochloride?
- La FDA no indica una escasez actual para los productos de este medicamento (datos de la FDA del 30 de octubre de 2026).
- ¿Se ha retirado del mercado Sapropterin dihydrochloride?
- Los informes de la FDA indican 2 retiros de productos de este medicamento; el más reciente comenzó el 22 de noviembre de 2024 (Clase III). Un retiro suele afectar a lotes concretos, no a todos los productos.
- ¿Quién fabrica Sapropterin dihydrochloride?
- 10 empresas tienen productos con receta de Sapropterin dihydrochloride en el directorio NDC de la FDA, entre ellas NorthStar RxLLC, Camber Pharmaceuticals, Inc. y Par Health USA, LLC.
Para qué se usa Sapropterin dihydrochloride
Cita de la sección «Indications and Usage» (indicaciones y uso) de la etiqueta aprobada por la FDA. Se muestra en inglés, tal como la publica la FDA.
KUVAN ® is indicated to reduce blood phenylalanine (Phe) levels in adult and pediatric patients one month of age and older with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin- (BH4-) responsive Phenylketonuria (PKU). KUVAN is to be used in conjunction with a Phe-restricted diet. …
— Etiqueta de la FDA: Kuvan, BioMarin Pharmaceutical Inc., vigente desde el 26 de agosto de 2024. Leer la etiqueta completa en DailyMed →
Etiqueta citada: la de la presentación más común (powder, for solution, oral), Kuvan, BioMarin Pharmaceutical Inc.; abarca 3 productos del directorio NDC de la FDA. Las citas sobre efectos secundarios, interacciones, dosis y embarazo de abajo vienen de esta misma etiqueta.
La FDA tiene 16 etiquetas para productos de este medicamento (distintos fabricantes y presentaciones); los usos pueden variar. Revise la etiqueta de su propio medicamento.
Esta página no es un consejo médico. Hable con su médico o farmacéutico antes de empezar, dejar o cambiar cualquier medicamento.
Advertencia en recuadro
La advertencia en recuadro («caja negra») es la advertencia más seria de la FDA en la etiqueta de un medicamento, para riesgos graves o mortales.
La etiqueta citada arriba no tiene advertencia en recuadro.
0 de 16 etiquetas de la FDA de este medicamento tienen advertencia en recuadro.
Efectos secundarios de Sapropterin dihydrochloride
Cita de la sección «Adverse Reactions» (reacciones adversas) de la etiqueta aprobada por la FDA. Se muestra en inglés. Avise a su médico de cualquier efecto secundario que le preocupe.
Most common adverse reactions (≥4%) are: headache, rhinorrhea, pharyngolaryngeal pain, diarrhea, vomiting, cough, and nasal congestion.
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(6.1) To report SUSPECTED ADVERSE REACTIONS, contact BioMarin Pharmaceutical Inc. at 1-877-695-8826, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. PKU Clinical Studies The safety of KUVAN was evaluated in 7 clinical studies in patients with PKU (aged 1 month to 50 years) [see Clinical Studies (14)]. In Studies 1-4 (controlled and uncontrolled studies), 579 patients with PKU aged 4 to 49 years received KUVAN in doses ranging from 5 to 20 mg/kg per day for lengths of treatment ranging from 1 to 164 weeks. The patient population was evenly distributed in gender, and approximately 95% of patients were Caucasian. The most common adverse reactions (≥4% of patients) were headache, rhinorrhea, pharyngolaryngeal pain, diarrhea, vomiting, cough, and nasal congestion. The data described in Table 3 reflect exposure of 74 patients with PKU to KUVAN at doses of 10 to 20 mg/kg per day for 6 to 10 weeks in two double-blind, placebo-controlled clinical trials (Studies 2 and 4). Table 3 enumerates adverse reactions occurring in at least 4% of patients treated with KUVAN in the double-blind, placebo-controlled clinical trials described above. Table 3: Summary of Adverse Reactions Occurring in ≥4% of Patients in Placebo-Controlled Clinical Studies with KUVAN MedDRA Preferred Term Treatment KUVAN (N=74) Placebo (N=59) No. Patients (%) No. Patients (%) Headache 11 (15) 8 (14) Rhinorrhea 8 (11) 0 Pharyngolaryngeal pain 7 (10) 1 (2) Diarrhea 6 (8) 3 (5) Vomiting 6 (8) 4 (7) Cough 5 (7) 3 (5) Nasal congestion 3 (4) 0 In open-label, uncontrolled clinical trials (Studies 1 and 3) all patients received KUVAN in doses of 5 to 20 mg/kg per day, and adverse reactions were similar in type and frequency to those reported in the double-blind, placebo-controlled clinical trials [see Clinical Studies (14)]. In Study 5, 65 pediatric patients with PKU aged 1 month to 6 years received KUVAN 20 mg/kg per day for 6 months. Adverse reactions in these patients were similar in frequency and type as those seen in other KUVAN clinical trials except for an increased incidence of low Phe levels. Twenty-five percent (16 out of 65) of patients developed Phe levels below normal for age [see Warnings and Precautions (5.3), Use In Specific Populations (8.4), and Clinical Studies (14)].
Tabla de la etiqueta
| MedDRA Preferred Term | Treatment | |
|---|---|---|
| KUVAN(N=74) | Placebo(N=59) | |
| No. Patients (%) | No. Patients (%) | |
| Headache | 11 (15) | 8 (14) |
| Rhinorrhea | 8 (11) | 0 |
| Pharyngolaryngeal pain | 7 (10) | 1 (2) |
| Diarrhea | 6 (8) | 3 (5) |
| Vomiting | 6 (8) | 4 (7) |
| Cough | 5 (7) | 3 (5) |
| Nasal congestion | 3 (4) | 0 |
— Etiqueta de la FDA: Kuvan, BioMarin Pharmaceutical Inc., vigente desde el 26 de agosto de 2024. Esto es solo una parte de la sección. Leer la etiqueta completa en DailyMed →
Interacciones de Sapropterin dihydrochloride
Cita de la sección «Drug Interactions» (interacciones) de la etiqueta aprobada por la FDA. Se muestra en inglés. Dígale a su farmacéutico todos los medicamentos, vitaminas y productos herbales que toma.
Table 4 includes drugs with clinically important drug interactions when administered with sapropterin dihydrochloride and instructions for preventing or managing them. Table 4: Clinically Relevant Drug Interactions Levodopa Clinical Impact Sapropterin dihydrochloride may increase the availability of tyrosine, a precursor of levodopa.
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Neurologic events were reported postmarketing in patients receiving sapropterin and levodopa concomitantly for a non-PKU indication [see Warnings and Precautions (5.5)]. Intervention Monitor patients for a change in neurologic status. Inhibitors of Folate Synthesis (e.g., methotrexate, valproic acid, phenobarbital, trimethoprim) Clinical Impact In vitro and in vivo nonclinical data suggest that drugs that inhibit folate synthesis may decrease the bioavailability of endogenous BH4 by inhibiting the enzyme dihydrofolate reductase, which is involved in the recycling (regeneration) of BH4. This reduction in net BH4 levels may increase Phe levels. Intervention Consider monitoring blood Phe levels more frequently during concomitant administration. An increased dosage of KUVAN may be necessary to achieve a biochemical response. Drugs Affecting Nitric Oxide‑Mediated Vasorelaxation (e.g., PDE-5 inhibitors such as sildenafil, vardenafil, or tadalafil) Clinical Impact Both sapropterin dihydrochloride and PDE-5 inhibitors may induce vasorelaxation. A reduction in blood pressure could occur; however, the combined use of these medications has not been evaluated in humans. Intervention Monitor blood pressure. Inhibitors of Folate Synthesis (e.g., methotrexate, valproic acid, phenobarbital, trimethoprim): Can decrease endogenous BH4 levels; monitor blood Phe levels more frequently and adjust KUVAN dosage as needed. (7) Drugs Affecting Nitric Oxide‑Mediated Vasorelaxation (e.g., PDE-5 inhibitors): Potential for vasorelaxation; monitor blood pressure. (7)
— Etiqueta de la FDA: Kuvan, BioMarin Pharmaceutical Inc., vigente desde el 26 de agosto de 2024. Esto es solo una parte de la sección. Leer la etiqueta completa en DailyMed →
Dosis de Sapropterin dihydrochloride
Cita de la sección «Dosage and Administration» (dosis y administración) de la etiqueta aprobada por la FDA. Se muestra en inglés. Su dosis es la que le receta su médico: no la cambie por su cuenta.
All patients with PKU who are being treated with KUVAN should also be treated with a Phe-restricted diet, including dietary protein and Phe restriction. (2.1) Starting Dosage Pediatric patients 1 month to 6 years: The recommended starting dosage of KUVAN is 10 mg/kg administered orally once daily. (2.2) Patients 7 years and older: The recommended starting dosage of KUVAN is 10 to 20 mg/kg administered orally once daily.
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(2.2) Dosage Adjustment Doses of KUVAN may be adjusted in the range of 5 to 20 mg/kg taken once daily. (2.2) Monitor blood Phe regularly, especially in pediatric patients. (2.2, 5.3) Preparation and Administration See the full prescribing information for preparation and administration instructions. (2.3) 2.1 Recommendations Prior to KUVAN Treatment Treatment with KUVAN should be directed by physicians knowledgeable in the management of PKU. All patients with PKU who are being treated with KUVAN should also be treated with a Phe-restricted diet, including dietary protein and Phe restriction. 2.2 Recommended Dosage and Administration The recommended starting dosage of KUVAN is: Pediatric Patients 1 month to 6 years: 10 mg/kg (actual body weight) administered orally once daily. Patients 7 years and older: 10 to 20 mg/kg (actual body weight) administered orally once daily. Administer KUVAN with a meal, preferably at the same time each day [see Clinical Pharmacology (12.3)]. A missed dose should be administered as soon as possible, but two doses should not be administered on the same day. Evaluation Period Existing dietary protein and Phe intake should not be modified during the evaluation period. If a 10 mg/kg per day starting dose is used, then response to therapy is determined by change in blood Phe following treatment with KUVAN at 10 mg/kg per day for a period of up to 1 month. Blood Phe levels should be checked after 1 week of KUVAN treatment and periodically for up to a month. If blood Phe does not decrease from baseline at 10 mg/kg per day, the dose may be increased to 20 mg/kg per day. Patients whose blood Phe does not decrease after 1 month of treatment at 20 mg/kg per day do not show a biochemical response and treatment with KUVAN should be discontinued in these patients. If a 20 mg/kg per day starting dose is used, then response to therapy is determined by change in blood Phe following treatment with KUVAN at 20 mg/kg per day for a period of 1 month. Blood Phe levels should be checked after 1 week of KUVAN treatment and periodically during the first month. Treatment should be discontinued in patients who do not show a biochemical response (blood Phe does not decrease) after 1 month of treatment at 20 mg/kg per day [see Warnings and Precautions (5.4)]. Dosage Adjustment Once responsiveness to KUVAN has been established, the dosage may be adjusted within the range of 5 to 20 mg/kg per day according to biochemical response to therapy (blood Phe).
Tabla de la etiqueta
| PatientWeight (kg) | Starting Dose: 10 mg/kg per day* | |||
|---|---|---|---|---|
| Dose (mg) | KUVAN Powder for Oral Solution 100 mg Packets Dissolved† | Dilution Volume (mL)‡ | Administered Dose volume (mL)§ | |
| 1 | 10 | 1 | 10 | 1 |
| 2 | 20 | 1 | 10 | 2 |
| 3 | 30 | 1 | 10 | 3 |
| 4 | 40 | 1 | 10 | 4 |
| 5 | 50 | 1 | 10 | 5 |
| 6 | 60 | 1 | 5 | 3 |
| 7 | 70 | 1 | 5 | 3.5 |
| 8 | 80 | 1 | 5 | 4 |
| 9 | 90 | 1 | 5 | 4.5 |
| 10 | 100 | 1 | 5 | 5 |
— Etiqueta de la FDA: Kuvan, BioMarin Pharmaceutical Inc., vigente desde el 26 de agosto de 2024. Esto es solo una parte de la sección. Leer la etiqueta completa en DailyMed →
Sapropterin dihydrochloride en el embarazo
Cita de la parte sobre embarazo (Pregnancy) de la etiqueta aprobada por la FDA. Se muestra en inglés. Pregunte a su médico antes de tomar cualquier medicamento si está embarazada o planea estarlo.
Risk Summary Available data from pregnancy safety studies, pharmacovigilance, and published case reports with KUVAN use during pregnancy have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data). Uncontrolled blood phenylalanine concentrations before and during pregnancy are associated with an increased risk of adverse pregnancy outcomes and fetal adverse effects (see Clinical Considerations).
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An embryo-fetal development study with sapropterin dihydrochloride in rats using oral doses up to 3 times the maximum recommended human dose (MRHD) given during the period of organogenesis showed no effects. In a rabbit study using oral administration of sapropterin dihydrochloride during the period of organogenesis, a rare defect, holoprosencephaly, was noted at 10 times the MRHD. All pregnancies have a background risk of major birth defects, pregnancy loss, or other adverse pregnancy outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. The estimated background risk of major birth defects and miscarriage in pregnant women with PKU who maintain blood phenylalanine concentrations greater than 600 micromol/L during pregnancy is greater than the corresponding background risk for pregnant women without PKU. Clinical Considerations Disease-Associated Maternal and/or Embryo‑Fetal Risk Uncontrolled blood phenylalanine concentrations before and during pregnancy are associated with an increased risk of adverse pregnancy outcomes and fetal adverse effects. To reduce the risk of hyperphenylalaninemia-induced fetal adverse effects, blood phenylalanine concentrations should be maintained between 120 and 360 micromol/L during pregnancy and during the 3 months before conception [see Dosage and Administration 2.2)]. Data Human Data Uncontrolled Maternal PKU Available data from the Maternal Phenylketonuria Collaborative Study on 468 pregnancies and 331 live births in PKU‑affected women demonstrated that uncontrolled Phe levels above 600 micromol/L are associated with a very high incidence of neurological, cardiac, facial dysmorphism, and growth anomalies. Control of blood phenylalanine during pregnancy is essential to reduce the incidence of Phe-induced teratogenic effects. Pregnancy Registry Data Available data from pregnancy sub-registries within the Phenylketonuria Developmental Outcomes and Safety (PKUDOS) Registry and the KUVAN Adult Maternal Pediatric European Registry (KAMPER) have identified 72 live births (79 pregnancies) in women with PKU exposed to sapropterin during pregnancy. Three birth defects were reported, including one case each of microcephaly, cleft palate, and tongue tie. The two major birth defects (microcephaly and cleft palate) were associated with Phe levels greater than 360 micromol/L during pregnancy. Animal Data No effects on embryo-fetal development were observed in a reproduction study in rats using oral doses of up to 400 mg/kg per day sapropterin dihydrochloride (about 3 times the MRHD of 20 mg/kg per day, based on body surface area) administered during the period of organogenesis.
— Etiqueta de la FDA: Kuvan, BioMarin Pharmaceutical Inc., vigente desde el 26 de agosto de 2024. Esto es solo una parte de la sección. Leer la etiqueta completa en DailyMed →
Sobredosis de Sapropterin dihydrochloride
Cita de la sección «Overdosage» (sobredosis) de la etiqueta aprobada por la FDA. Se muestra en inglés. Si alguien pudo haber tomado demasiado, llame a Poison Help al 1-800-222-1222 (o al 911 en una emergencia).
Two unintentional overdosages with KUVAN have been reported. One adult patient in a KUVAN clinical trial received a single KUVAN dose of 4,500 mg (36 mg/kg) instead of 2,600 mg (20 mg/kg). The patient reported mild headache and mild dizziness immediately after taking the dose; both symptoms resolved within 1 hour with no treatment intervention. There were no associated laboratory test abnormalities.
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The patient suspended therapy for 24 hours and then restarted KUVAN with no reports of abnormal signs or symptoms. In postmarketing, one pediatric patient received KUVAN doses of 45 mg/kg per day instead of 20 mg/kg per day. The patient reported hyperactivity that began at an unspecified time after overdosage and resolved after the KUVAN dose was reduced to 20 mg/kg per day. In a clinical study to evaluate the effects of KUVAN on cardiac repolarization, a single supra-therapeutic dose of 100 mg/kg (5 times the maximum recommended dose) was administered to 54 healthy adults. No serious adverse reactions were reported during the study. The only adverse reactions reported in more than 1 subject who received the supra-therapeutic dose were upper abdominal pain (6%) and dizziness (4%). A dose-dependent shortening of the QT interval was observed [see Clinical Pharmacology (12.2)]. Patients should be advised to notify their physicians in cases of overdosage.
— Etiqueta de la FDA: Kuvan, BioMarin Pharmaceutical Inc., vigente desde el 26 de agosto de 2024. Leer la etiqueta completa en DailyMed →
Presentaciones y vía de administración
Empresas que tienen este medicamento
Empresas en el directorio NDC de la FDA: la empresa que aparece en el envase (fabricante o distribuidor), con su número de productos con receta.
- NorthStar RxLLC3 productos
- Camber Pharmaceuticals, Inc.3 productos
- Par Health USA, LLC3 productos
- BioMarin Pharmaceutical Inc.3 productos
- Dr.Reddys Laboratories Inc3 productos
- Aucta Pharmaceuticals, Inc.2 productos
- Micro Labs Limited2 productos
- TruPharma, LLC2 productos
- Aurobindo Pharma Limited1 producto
- Hikma Pharmaceuticals USA Inc.1 producto
Historial de aprobación de la FDA
- NDA: Solicitud de nuevo medicamento (NDA): así se aprueba un medicamento nuevo, normalmente de marca.
- ANDA: Solicitud abreviada (ANDA): así se aprueba una versión genérica.
| Solicitud | Patrocinador | Aprobada | Cambios aprobados después |
|---|---|---|---|
| NDA022181 KUVAN | Biomarin Pharm | 13 de diciembre de 2007 | 12, el último 26 de agosto de 2024 2024: Etiquetado · 2020: Etiquetado · 2019: Etiquetado |
| NDA205065 KUVAN | Biomarin Pharm | 19 de diciembre de 2013 | 6, el último 26 de agosto de 2024 2024: Etiquetado · 2020: Etiquetado · 2019: Etiquetado |
Aprobaciones de genéricos (13)
- ANDA207200Ph Health · 10 de mayo de 2019
- ANDA207207Ph Health · 20 de agosto de 2019
- ANDA210027Ph Health · 20 de agosto de 2019
- ANDA209452DR Reddys · 30 de marzo de 2021
- ANDA207685DR Reddys · 15 de junio de 2021
- ANDA215798DR Reddys · 13 de mayo de 2022
- ANDA215420Annora Pharma · 18 de agosto de 2022
- ANDA215534Annora Pharma · 23 de agosto de 2022
- ANDA218645Aucta · 29 de abril de 2025
- ANDA216797Aurobindo Pharma · 9 de junio de 2025
- ANDA218797Hikma · 11 de junio de 2025
- ANDA216432Hopewell Pharma · 3 de septiembre de 2025
- ANDA219511Micro Labs · 8 de enero de 2026
Escasez
La lista de escasez de la FDA no incluye estos productos.
Retiros del mercado
De los informes de la FDA, vinculados por el código NDC del producto. Un retiro suele afectar solo a lotes concretos: revise el número de lote del envase y pregunte a su farmacéutico. No deje un medicamento por su cuenta.
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22 de noviembre de 2024 · Clase III · En curso · D-0117-2025
Failed Impurities/Degradation Specifications
Javygtor (sapropterin dihydrochloride) Tablets 100mg, 120-count bottle, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 Made in India, NDC 43598-096-04. — Dr. Reddy's Laboratories, Inc.
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8 de abril de 2024 · Clase I · En curso · D-0485-2024
Sub-potent Drug; powder discoloration associated with decreased potency
Javygtor (sapropterin dihydrochloride) Powder for Oral Solution 100mg, 30 individual packets per carton, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 Made in India, NDC 43598-097-30. — Dr. Reddy's Laboratories, Inc.
¿Qué significan las clases de retiro?
Clase I: El tipo más grave: existe una probabilidad razonable de que usar el producto cause problemas de salud graves o la muerte.
Clase II: Usar el producto puede causar problemas de salud temporales o reversibles con tratamiento, o la probabilidad de problemas graves es remota.
Clase III: No es probable que usar el producto cause problemas de salud (por ejemplo, un problema de etiquetado o de envase).
Identificadores oficiales
Siguientes pasos
- Encuentre una farmacia cerca de ustedPregunte qué precio le corresponde y si su producto está afectado por un retiro
- Últimos retiros de medicamentos de la FDATodos los medicamentos, los más recientes primero
- JavygtorPágina de marca: productos, fabricante y precio
- KuvanPágina de marca: productos, fabricante y precio
- ZelvysiaPágina de marca: productos, fabricante y precio
- NorthStar RxLLCFabricante o distribuidor
- Camber Pharmaceuticals, Inc.Fabricante o distribuidor
- Par Health USA, LLCFabricante o distribuidor
- Todos los medicamentos con receta de la A a la ZBusque por nombre genérico, de marca o en español
Fuentes
- Etiqueta aprobada por la FDA en DailyMed (Biblioteca Nacional de Medicina) — Kuvan, BioMarin Pharmaceutical Inc., vigente desde el 26 de agosto de 2024; vía openFDA, datos de la FDA exportados el 30 de octubre de 2026, consultados el 31 de octubre de 2026
- NDC Directory (openFDA) — Administración de Alimentos y Medicamentos de los EE. UU. (FDA), datos de la FDA exportados el 30 de octubre de 2026, consultados el 31 de octubre de 2026
- Drugs@FDA (openFDA) — Administración de Alimentos y Medicamentos de los EE. UU. (FDA), datos de la FDA exportados el 30 de octubre de 2026, consultados el 31 de octubre de 2026
- Drug recall enforcement reports (openFDA) — Administración de Alimentos y Medicamentos de los EE. UU. (FDA), datos de la FDA exportados el 27 de octubre de 2026, consultados el 31 de octubre de 2026
- Drug shortages (openFDA) — Administración de Alimentos y Medicamentos de los EE. UU. (FDA), datos de la FDA exportados el 30 de octubre de 2026, consultados el 31 de octubre de 2026
La FDA ofrece los datos de openFDA tal cual; pueden estar incompletos. Guíese siempre por la etiqueta que viene con su medicamento. Buscador de informes de retiros de la FDA →
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