FDA.reportPublic FDA data

Application 210895

Type
NDA
Sponsor
DAIICHI SANKYO INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001WELCHOLCOLESEVELAM HYDROCHLORIDEBAR, CHEWABLE;ORAL3.75GMYesYes

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N210895-001WELCHOLCOLESEVELAM HYDROCHLORIDE3.75GMBAR, CHEWABLE / ORALRLD2019-04-03

openFDA label cross-check#

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Colesevelam hydrochlorideCOLESEVELAM HYDROCHLORIDEBryant Ranch Prepackdbed6967-b261-44a1-bee4-638810e2efe92026-05-26Warnings, Adverse reactionsName fallback
COLESEVELAM HYDROCHLORIDECOLESEVELAM HYDROCHLORIDEBionpharma Inc.4aa52225-9214-59dc-e063-6294a90a5f752026-02-12Warnings, Adverse reactionsName fallback
colesevelam hydrochlorideCOLESEVELAM HYDROCHLORIDEGlenmark Pharmaceuticals Inc., USA845b8661-0aa9-418f-a496-df3d7a3130ff2026-01-29Warnings, Adverse reactionsName fallback
Colesevelam HydrochlorideCOLESEVELAM HYDROCHLORIDEGlenmark Pharmaceuticals Inc.,USA2e736dd4-bb64-4f93-9821-7c24ea7d38ec2026-01-28Warnings, Adverse reactionsName fallback
COLESEVELAM HYDROCHLORIDECOLESEVELAM HYDROCHLORIDEGolden State Medical Supply, Inc.c7058806-ad4f-6d5f-e053-2a95a90a35e82025-12-10Warnings, Adverse reactionsName fallback
Colesevelam HydrochlorideCOLESEVELAM HYDROCHLORIDEAmerican Health Packaging87bf6310-cfc4-4cb4-966e-8561b3880e362025-12-05Warnings, Adverse reactionsName fallback
Colesevelam hydrochlorideCOLESEVELAM HYDROCHLORIDEA-S Medication Solutions0f235408-e28d-4cce-b7f1-66bbe0e4534c2025-07-17Warnings, Adverse reactionsName fallback
Colesevelam hydrochlorideCOLESEVELAM HYDROCHLORIDEA-S Medication Solutionsb48a7426-b513-4790-99a4-4f07d83318d72025-07-16Warnings, Adverse reactionsName fallback
Colesevelam HydrochlorideCOLESEVELAM HYDROCHLORIDEMacleods Pharmaceuticals Limitedc2075dd1-e33c-4438-95f8-1897f0e1f61a2025-05-05Warnings, Adverse reactionsName fallback
COLESEVELAM HYDROCHLORIDECOLESEVELAM HYDROCHLORIDEBionpharma Inc.a2c5e881-2901-4f90-95cc-74930569e51e2025-03-19Warnings, Adverse reactionsName fallback
colesevelam hydrochlorideCOLESEVELAM HYDROCHLORIDEA-S Medication Solutions67820d4f-0cfb-43ca-8974-08dffe4749832024-11-18Warnings, Adverse reactionsName fallback
colesevelam hydrochlorideCOLESEVELAM HYDROCHLORIDEA-S Medication Solutions79af88a5-b873-499b-a9a4-fc39624820fe2024-11-18Warnings, Adverse reactionsName fallback
Colesevelam HydrochlorideCOLESEVELAM HYDROCHLORIDEAmneal Pharmaceuticals of New York LLCf5306376-e7f2-44ad-8250-635b95428a7c2024-10-29Warnings, Adverse reactionsName fallback
Colesevelam hydrochlorideCOLESEVELAM HYDROCHLORIDECranbury Pharmaceuticals, LLC5e50cc0c-03bc-444b-9d15-ea112bc0f91c2024-07-31Warnings, Adverse reactionsName fallback
Colesevelam hydrochlorideCOLESEVELAM HYDROCHLORIDEBryant Ranch Prepack652fbd7b-2702-4db6-8691-be93c61bd9d62024-07-25Warnings, Adverse reactionsName fallback
COLESEVELAM HYDROCHLORIDECOLESEVELAM HYDROCHLORIDEA-S Medication Solutions0127afae-8d8d-43f2-97f9-4f99f6947e812023-12-28Warnings, Adverse reactionsName fallback
COLESEVELAM HYDROCHLORIDECOLESEVELAM HYDROCHLORIDEA-S Medication Solutions40d66c9d-ff51-4353-8133-ae3a8eb4f7132023-12-28Warnings, Adverse reactionsName fallback
Colesevelam HydrochlorideCOLESEVELAM HYDROCHLORIDEDr.Reddys Laboratories Inc28701657-640a-67d6-e56f-cf5c672c6e2a2023-06-30Warnings, Adverse reactionsName fallback
Colesevelam hydrochlorideCOLESEVELAM HYDROCHLORIDEAscend Laboratories, LLCdfce5bc5-58fc-4fe5-b5c0-7a8026ee2b962023-02-16Warnings, Adverse reactionsName fallback
Colesevelam hydrochlorideCOLESEVELAM HYDROCHLORIDEAmneal Pharmaceuticals of New York LLCf33fbf30-2486-49a7-bbe8-0ddfb4b9b7862022-10-18Warnings, Adverse reactionsName fallback

Warnings cross-check#

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warnings and cautions

5 WARNINGS AND PRECAUTIONS Hypertriglyceridemia and Pancreatitis: Colesevelam hydrochloride can increase TG. Hypertriglyceridemia can cause acute pancreatitis. Monitor lipids, including TG . Instruct patients to discontinue colesevelam hydrochloride and seek prompt medical attention if the symptoms of acute pancreatitis occur ( 5.1 ). Gastrointestinal Obstruction: Cases of bowel obstruction have occurred. Colesevelam hydrochloride is not recommended in patients with gastroparesis, other gastrointestinal motility disorders, and in those who have had major gastrointestinal tract surgery and who may be at risk for bowel obstruction ( 5.2 ). Vitamin K or Fat-Soluble Vitamin Deficiencies: Colesevelam hydrochloride may decrease absorption of fat-soluble vitamins. Patients with a susceptibility to deficiencies of vitamin K (e.g., patients on warfarin, patients with malabsorption syndromes) or other fat-soluble vitamins may be at increased risk. Patients on oral vitamin supplementation should take their vitamins at least 4 hours prior to colesevelam hydrochloride ( 5.3 ). Drug Interactions: Due to the potential for decreased absorption of other drugs that have not been tested for interaction, consider administering at least 4 hours prior to colesevelam hydrochloride ( 5.4 , 7 , 12.3 ). Risks in Patients with Phenylketonuria (PKU) : Phenylalanine can be harmful to patients with phenylketonuria. Colesevelam hydrochloride for oral suspension contains 33.6 mg phenylalanine per 3.75 gram packet ( 5.5 , 11 ). 5.1 Hypertriglyceridemia and Pancreatitis Colesevelam hydrochloride, like other bile acid sequestrants, can increase serum TG concentrations. Hypertriglyceridemia can cause acute pancreatitis. Colesevelam hydrochloride had effects on serum TG (median increase 5% compared to placebo) in trials of patients with primary hyperlipidemia. Obtain lipid parameters, including TG levels, before starting colesevelam hydrochloride and periodically thereafter. Colesevelam hydrochloride is contraindicated in patients with TG levels greater than 500 mg/dL or patients with a history of hypertriglyceridemia-induced pancreatitis [see Contraindications ( 4 )] . Patients with TG levels greater than 300 mg/dL could have greater increases in serum TG levels with colesevelam hydrochloride and may require additional TG monitoring. Instruct patients to discontinue colesevelam hydrochlorid...

Adverse reactions cross-check#

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adverse reactions

6 ADVERSE REACTIONS The following important adverse reactions are described below and elsewhere in the labeling: Hypertriglyceridemia and Pancreatitis [see Warnings and Precautions ( 5.1 )] Gastrointestinal Obstruction [see Warnings and Precautions ( 5.2 )] Vitamin K or Fat-Soluble Vitamin Deficiencies [see Warnings and Precautions ( 5.3 )] In clinical trials, the most common (incidence ≥2% and greater than placebo) adverse reactions with Colesevelam hydrochloride included constipation, dyspepsia, and nausea ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Ascend Laboratories, LLC at 1-877-ASC-RX01 (877-272-7901) or FDA at 1-800-FDA-1088 or www.fda.gov /medwatch . 6.1 Clinical Studies Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in clinical studies of another drug and may not reflect the rates observed in practice. Primary Hyperlipidemia In 7 double-blind, placebo-controlled clinical trials, 807 patients with primary hyperlipidemia (age range 18 to 86 years, 50% women, 90% Caucasians, 7% Blacks, 2% Hispanics, 1% Asians) and elevated LDL-C were treated with colesevelam hydrochloride 1.5 g/day to 4.5 g/day from 4 to 24 weeks (total exposure 199 patient-years). Table 1 Clinical Studies of Colesevelam Hydrochloride for Primary Hyperlipidemia: Adverse Reactions Reported in ≥ 2% of Patients and More Commonly than in Placebo Colesevelam hydrochloride N = 807 Placebo N = 258 Constipation 11.0% 7.0% Dyspepsia 8.3% 3.5% Nausea 4.2% 3.9% Accidental injury 3.7% 2.7% Asthenia 3.6% 1.9% Pharyngitis 3.2% 1.9% Flu syndrome 3.2% 3.1% Rhinitis 3.2% 3.1% Myalgia 2.1% 0.4% Pediatric Patients 10 to 17 Years of Age In an 8-week double-blind, placebo-controlled study, boys and post-menarchal girls, 10 to 17 years of age, with HeFH (n=194), were treated with colesevelam hydrochloride tablets (1.9 to 3.8 g, daily) or placebo tablets. Table 2 Clinical Study of Colesevelam Hydrochloride for Primary Hyperlipidemia in HeFH Pediatric Patients: Adverse Reactions Reported in ≥2% of Patients and More Commonly than in Placebo Colesevelam Hydrochloride N = 129 Placebo N = 65 Nasopharyngitis 6.2% 4.6% Headache 3.9% 3.1% Fatigue 3.9% 1.5% Creatine Phosphokinase Increase 2.3% 0.0% Rhinitis 2.3% 0.0% Vomiting 2.3% 1.5% The reported adverse reaction...

adverse reactions table

Colesevelam hydrochloride N = 807 Placebo N = 258 Constipation 11.0% 7.0% Dyspepsia 8.3% 3.5% Nausea 4.2% 3.9% Accidental injury 3.7% 2.7% Asthenia 3.6% 1.9% Pharyngitis 3.2% 1.9% Flu syndrome 3.2% 3.1% Rhinitis 3.2% 3.1% Myalgia 2.1% 0.4%

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
65597-208Welcholcolesevelam hydrochlorideDaiichi Sankyo Inc.NDACurrent
65597-208Welcholcolesevelam hydrochlorideDaiichi Sankyo Inc.NDACurrent
65597-208Welcholcolesevelam hydrochlorideDaiichi Sankyo Inc.NDACurrent
65597-209Welcholcolesevelam hydrochlorideDaiichi Sankyo Inc.NDACurrent
65597-209Welcholcolesevelam hydrochlorideDaiichi Sankyo Inc.NDACurrent
65597-209Welcholcolesevelam hydrochlorideDaiichi Sankyo Inc.NDACurrent
65597-210Welcholcolesevelam hydrochlorideDaiichi Sankyo Inc.NDACurrent
65597-210Welcholcolesevelam hydrochlorideDaiichi Sankyo Inc.NDACurrent
65597-210Welcholcolesevelam hydrochlorideDaiichi Sankyo Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
62963SUPPL2020-05-13
62958SUPPL2020-05-13
59903ORIG2019-09-03
58200ORIG2019-09-03
58211ORIG2019-04-04
64997ORIG1900-01-01
64996ORIG1900-01-01
62921ORIG1900-01-01