FDA.reportPublic FDA data

Application 206030

Type
NDA
Sponsor
LUNDBECK PHARMS LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CARNEXIVCARBAMAZEPINESOLUTION;INTRAVENOUS200MG/20ML (10MG/ML)YesNo

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N206030-001CARNEXIVCARBAMAZEPINE200MG/20ML (10MG/ML)SOLUTION / INTRAVENOUSRLD2016-10-07

Orange Book patents#

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N206030-00196297972028-11-10U-20042017-05-10
N206030-00196297972028-11-10U-20052017-05-10
N206030-00196297972028-11-10U-20062017-05-10
N206030-00197704072028-11-10Drug product2017-10-04
N206030-00176357732029-03-13Drug product2016-10-18
N206030-00184100772029-03-13Drug product2016-10-18
N206030-00197508222029-03-13Drug product2017-10-27
N206030-00194935822033-02-27Drug product2016-12-08
N206030-001115293572040-01-31Drug product2023-01-17

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CarbamazepineCARBAMAZEPINEREMEDYREPACK INC.9f3d91cd-a959-4e07-a51b-8a4e9ba9ece22026-07-29Boxed warning, Warnings, Adverse reactionsName fallback
CARBAMAZEPINECARBAMAZEPINEAmerican Health Packaging7108d630-89bc-4815-b6fb-a1f4676c496e2026-07-24Boxed warning, Warnings, Adverse reactionsName fallback
CarbamazepineCARBAMAZEPINEREMEDYREPACK INC.9471b7fb-29d3-4009-9d0f-f20c27351db52026-07-23Boxed warning, Warnings, Adverse reactionsName fallback
CARBAMAZEPINECARBAMAZEPINETorrent Pharmaceuticals Limited97e6e175-75e8-437b-b457-ddb1ae4e857d2026-07-23Boxed warning, Warnings, Adverse reactionsName fallback
CarbamazepineCARBAMAZEPINEREMEDYREPACK INC.40bf2923-24b1-4af1-8d20-03cf06b455a52026-07-21Boxed warning, Warnings, Adverse reactionsName fallback
TegretolCARBAMAZEPINENovartis Pharmaceuticals Corporation8d409411-aa9f-4f3a-a52c-fbcb0c3ec0532026-07-15Boxed warning, Warnings, Adverse reactionsName fallback
CARBAMAZEPINECARBAMAZEPINEMajor Pharmaceuticals2a8c7366-ce89-47ce-8123-96f26812fca02026-07-14Boxed warning, Warnings, Adverse reactionsName fallback
CarbamazepineCARBAMAZEPINEREMEDYREPACK INC.d0121be3-b904-41d3-a81a-292aa41764912026-07-06Boxed warning, Warnings, Adverse reactionsName fallback
CARBAMAZEPINECARBAMAZEPINEBionpharma Inc.,138d9ed1-2f8e-d19d-e063-6394a90a695d2026-06-29Boxed warning, Warnings, Adverse reactionsName fallback
CarbamazepineCARBAMAZEPINEREMEDYREPACK INC.8cc7288c-4a7e-417c-9ceb-0e0f8aeeacb32026-06-25Boxed warning, Warnings, Adverse reactionsName fallback
CARBAMAZEPINECARBAMAZEPINECoupler LLC5461e739-0f18-b012-e063-6394a90a6b142026-06-16Boxed warning, Warnings, Adverse reactionsName fallback
CarbamazepineCARBAMAZEPINECoupler LLC544e3b55-c8a3-a480-e063-6394a90abbb52026-06-15Boxed warning, Warnings, Adverse reactionsName fallback
CARBAMAZEPINECARBAMAZEPINEREMEDYREPACK INC.5f9535b1-ff6a-41b3-bbb2-efcf8fbacf4c2026-06-10Boxed warning, Warnings, Adverse reactionsName fallback
CarbamazepineCARBAMAZEPINEREMEDYREPACK INC.cd8b51f4-8427-4b18-9d2c-10771d2a65802026-06-10Boxed warning, Warnings, Adverse reactionsName fallback
CarbamazepineCARBAMAZEPINEUmedica Laboratories USA Inc.f3465f71-8931-43b6-baea-eac7046a44002026-06-04Boxed warning, Warnings, Adverse reactionsName fallback
CarbamazepineCARBAMAZEPINEA-S Medication Solutions1dc2a4d3-2ebc-4c9b-a347-92acd9f231f22026-06-03Boxed warning, Warnings, Adverse reactionsName fallback
CarbamazepineCARBAMAZEPINEAjanta Pharma USA Inc.2e3c4854-89a1-4e3f-88d4-e164829585fb2026-06-01Boxed warning, Warnings, Adverse reactionsName fallback
CarbamazepineCARBAMAZEPINEBryant Ranch Prepackd3cd36c4-b25e-4716-be1d-0b2c83ea6a032026-05-28Boxed warning, Warnings, Adverse reactionsName fallback
CarbamazepineCARBAMAZEPINEUmedica Laboratories USA Inc.48080efd-1781-4585-83f8-c43957ac63b32026-05-26Boxed warning, Warnings, Adverse reactionsName fallback
Carbamazepine ERCARBAMAZEPINEOryza Pharmaceuticals Inc.34b375d0-68b0-4bd5-8ac9-be043b57e91c2026-05-14Boxed warning, Warnings, Adverse reactionsName fallback

Boxed warning cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

boxed warning

WARNINGS SERIOUS DERMATOLOGIC REACTIONS AND HLA-B*1502 ALLELE SERIOUS AND SOMETIMES FATAL DERMATOLOGIC REACTIONS, INCLUDING TOXIC EPIDERMAL NECROLYSIS (TEN) AND STEVENS-JOHNSON SYNDROME (SJS), HAVE BEEN REPORTED DURING TREATMENT WITH CARBAMAZEPINE. THESE REACTIONS ARE ESTIMATED TO OCCUR IN 1 TO 6 PER 10,000 NEW USERS IN COUNTRIES WITH MAINLY CAUCASIAN POPULATIONS, BUT THE RISK IN SOME ASIAN COUNTRIES IS ESTIMATED TO BE ABOUT 10 TIMES HIGHER. STUDIES IN PATIENTS OF CHINESE ANCESTRY HAVE FOUND A STRONG ASSOCIATION BETWEEN THE RISK OF DEVELOPING SJS/TEN AND THE PRESENCE OF HLA-B*1502, AN INHERITED ALLELIC VARIANT OF THE HLA-B GENE. HLA-B*1502 IS FOUND ALMOST EXCLUSIVELY IN PATIENTS WITH ANCESTRY ACROSS BROAD AREAS OF ASIA. PATIENTS WITH ANCESTRY IN GENETICALLY AT-RISK POPULATIONS SHOULD BE SCREENED FOR THE PRESENCE OF HLA-B*1502 PRIOR TO INITIATING TREATMENT WITH CARBAMAZEPINE. PATIENTS TESTING POSITIVE FOR THE ALLELE SHOULD NOT BE TREATED WITH CARBAMAZEPINE UNLESS THE BENEFIT CLEARLY OUTWEIGHS THE RISK (SEE WARNINGS AND PRECAUTIONS , LABORATORY TESTS ). APLASTIC ANEMIA AND AGRANULOCYTOSIS APLASTIC ANEMIA AND AGRANULOCYTOSIS HAVE BEEN REPORTED IN ASSOCIATION WITH THE USE OF CARBAMAZEPINE. DATA FROM A POPULATION-BASED CASE CONTROL STUDY DEMONSTRATE THAT THE RISK OF DEVELOPING THESE REACTIONS IS 5 TO 8 TIMES GREATER THAN IN THE GENERAL POPULATION. HOWEVER, THE OVERALL RISK OF THESE REACTIONS IN THE UNTREATED GENERAL POPULATION IS LOW, APPROXIMATELY SIX PATIENTS PER ONE MILLION POPULATION PER YEAR FOR AGRANULOCYTOSIS AND TWO PATIENTS PER ONE MILLION POPULATION PER YEAR FOR APLASTIC ANEMIA. ALTHOUGH REPORTS OF TRANSIENT OR PERSISTENT DECREASED PLATELET OR WHITE BLOOD CELL COUNTS ARE NOT UNCOMMON IN ASSOCIATION WITH THE USE OF CARBAMAZEPINE, DATA ARE NOT AVAILABLE TO ESTIMATE ACCURATELY THEIR INCIDENCE OR OUTCOME. HOWEVER, THE VAST MAJORITY OF THE CASES OF LEUKOPENIA HAVE NOT PROGRESSED TO THE MORE SERIOUS CONDITIONS OF APLASTIC ANEMIA OR AGRANULOCYTOSIS. BECAUSE OF THE VERY LOW INCIDENCE OF AGRANULOCYTOSIS AND APLASTIC ANEMIA, THE VAST MAJORITY OF MINOR HEMATOLOGIC CHANGES OBSERVED IN MONITORING OF PATIENTS ON CARBAMAZEPINE ARE UNLIKELY TO SIGNAL THE OCCURRENCE OF EITHER ABNORMALITY. NONETHELESS, COMPLETE PRETREATMENT HEMATOLOGICAL TESTING SHOULD BE OBTAINED AS A BASELINE. IF A PATIENT IN THE COURSE OF TREATMENT EXHIBITS LOW OR DECREASED WHITE BLOOD CELL OR PLAT...

Warnings cross-check#

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warnings and cautions

WARNINGS Serious Dermatologic Reactions Serious and sometimes fatal dermatologic reactions, including toxic epidermal necrolysis (TEN) and Stevens-Johnson syndrome (SJS), have been reported with carbamazepine treatment. The risk of these events is estimated to be about 1 to 6 per 10,000 new users in countries with mainly Caucasian populations. However, the risk in some Asian countries is estimated to be about 10 times higher. Carbamazepine should be discontinued at the first sign of a rash, unless the rash is clearly not drug-related. If signs or symptoms suggest SJS/TEN, use of this drug should not be resumed and alternative therapy should be considered. SJS/TEN and HLA-B*1502 Allele Retrospective case-control studies have found that in patients of Chinese ancestry there is a strong association between the risk of developing SJS/TEN with carbamazepine treatment and the presence of an inherited variant of the HLA-B gene, HLA-B*1502. The occurrence of higher rates of these reactions in countries with higher frequencies of this allele suggests that the risk may be increased in allele-positive individuals of any ethnicity. Across Asian populations, notable variation exists in the prevalence of HLA-B*1502. Greater than 15% of the population is reported positive in Hong Kong, Thailand, Malaysia, and parts of the Philippines, compared to about 10% in Taiwan and 4% in North China. South Asians, including Indians, appear to have intermediate prevalence of HLA-B*1502, averaging 2% to 4%, but higher in some groups. HLA-B*1502 is present in less than 1% of the population in Japan and Korea. HLA-B*1502 is largely absent in individuals not of Asian origin (e.g., Caucasians, African-Americans, Hispanics, and Native Americans). Prior to initiating carbamazepine therapy, testing for HLA-B*1502 should be performed in patients with ancestry in populations in which HLA-B*1502 may be present. In deciding which patients to screen, the rates provided above for the prevalence of HLA-B*1502 may offer a rough guide, keeping in mind the limitations of these figures due to wide variability in rates even within ethnic groups, the difficulty in ascertaining ethnic ancestry, and the likelihood of mixed ancestry. Carbamazepine should not be used in patients positive for HLA-B*1502 unless the benefits clearly outweigh the risks. Tested patients who are found to be negative for the allel...

warnings and cautions table

IndicationPlacebo patients with events per 1,000 patientsDrug patients with events per 1,000 patientsRelative risk: incidence of events in drug patients/incidence in placebo patientsRisk difference: additional drug patients with events per 1,000 patientsEpilepsy1.03.43.52.4Psychiatric5.78.51.52.9Other1.01.81.90.9Total2.44.31.81.9

Adverse reactions cross-check#

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adverse reactions

ADVERSE REACTIONS If adverse reactions are of such severity that the drug must be discontinued, the physician must be aware that abrupt discontinuation of any anticonvulsant drug in a responsive epileptic patient may lead to seizures or even status epilepticus with its life-threatening hazards. The most severe adverse reactions have been observed in the hemopoietic system and skin (see BOXED WARNING ), the liver, and the cardiovascular system. The most frequently observed adverse reactions, particularly during the initial phases of therapy, are dizziness, drowsiness, unsteadiness, nausea, and vomiting. To minimize the possibility of such reactions, therapy should be initiated at the lowest dosage recommended. The following additional adverse reactions have been reported: Hemopoietic System : Aplastic anemia, agranulocytosis, pancytopenia, bone marrow depression, thrombocytopenia, leukopenia, leukocytosis, eosinophilia, acute intermittent porphyria, variegate porphyria, porphyria cutanea tarda. Skin : TEN and SJS (see BOXED WARNING ), Acute Generalized Exanthematous Pustulosis (AGEP), pruritic and erythematous rashes, urticaria, photosensitivity reactions, alterations in skin pigmentation, exfoliative dermatitis, erythema multiforme and nodosum, purpura, aggravation of disseminated lupus erythematosus, alopecia, diaphoresis, onychomadesis and hirsutism. In certain cases, discontinuation of therapy may be necessary. Cardiovascular System : Congestive heart failure, edema, aggravation of hypertension, hypotension, syncope and collapse, aggravation of coronary artery disease, arrhythmias and AV block, thrombophlebitis, thromboembolism (e.g., pulmonary embolism), and adenopathy or lymphadenopathy. Some of these cardiovascular complications have resulted in fatalities. Myocardial infarction has been associated with other tricyclic compounds. Liver : Abnormalities in liver function tests, cholestatic and hepatocellular jaundice, hepatitis, very rare cases of hepatic failure. Pancreatic : Pancreatitis. Respiratory System : Pulmonary hypersensitivity characterized by fever, dyspnea, pneumonitis, or pneumonia. Genitourinary System : Urinary frequency, acute urinary retention, oliguria with elevated blood pressure, azotemia, renal failure, and impotence. Albuminuria, glycosuria, elevated BUN, and microscopic deposits in the urine have also been reported. There have ...

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
67386-621CARNEXIVCarbamazepineLundbeck Pharmaceuticals LLCNDACurrent
67386-621CARNEXIVCarbamazepineLundbeck Pharmaceuticals LLCNDACurrent
67386-621CARNEXIVCarbamazepineLundbeck Pharmaceuticals LLCNDACurrent
67386-621CARNEXIVCarbamazepineLundbeck Pharmaceuticals LLCNDACurrent
67386-621CARNEXIVCarbamazepineLundbeck Pharmaceuticals LLCNDACurrent
67386-621CARNEXIVCarbamazepineLundbeck Pharmaceuticals LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
61267SUPPL2019-12-13
61264SUPPL2019-12-13
50467ORIG2017-11-21
45609ORIG2016-10-12
45521ORIG2016-10-12