FDA.reportPublic FDA data

Application 205067

Type
ANDA
Sponsor
DR REDDYS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PROPOFOLPROPOFOLINJECTABLE;INJECTION10MG/MLNoNo

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A205067-001PROPOFOLPROPOFOL10MG/MLINJECTABLE / INJECTIONAB2018-11-15

Therapeutic equivalence codes#

Application-product, TE code table
Application-productTE code
A205067-001AB

openFDA label cross-check#

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Propofol Injectable EmulsionPROPOFOL INJECTABLE EMULSIONDr. Reddy's Laboratories, Inc.800646b8-83a8-01d9-3dc8-bb2ddcb8570c2022-09-30Warnings, Adverse reactionsExact identifier

Warnings cross-check#

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warnings and cautions

5 WARNINGS AND PRECAUTIONS Hypersensitivity Reactions : Serious and sometimes fatal reactions ( 5.1 ) Microbial Contamination : Strict aseptic technique must be maintained during handling. Propofol injectable emulsion vials are never to be accessed more than once or used on more than one person. Administration should commence promptly and be completed within 12 hours after the vial has been opened. Discard unused drug product. Do not use if contamination is suspected ( 5.2 ) Cardiovascular depression : Cases of bradycardia, asystole, and cardiac arrest have been reported. Pediatric patients are susceptible to this effect, particularly when fentanyl is given concomitantly ( 5.4 ) 5.1 Anaphylactic and Anaphylactoid Reactions Use of propofol injectable emulsion has been associated with both fatal and life threatening anaphylactic and anaphylactoid reactions. Clinical features of anaphylaxis, including angioedema, bronchospasm, erythema, and hypotension, occur rarely following propofol injectable emulsion administration. 5.2 Risks of Microbial Contamination Strict aseptic technique must always be maintained during handling. Propofol injectable emulsion is a single-dose parenteral product (single patient infusion vial) which contains 0.15% benzyl alcohol to inhibit the rate of growth of microorganisms, for up to 12 hours, in the event of accidental extrinsic contamination. However, propofol injectable emulsion can still support the growth of microorganisms, as it is not an antimicrobially preserved product under USP standards. Do not use if contamination is suspected. Discard unused drug product as directed within the required time limits. There have been reports in which failure to use aseptic technique when handling propofol injectable emulsion was associated with microbial contamination of the product and with fever, infection/sepsis, other life-threatening illness, and/or death. Propofol injectable emulsion vials are never to be accessed more than once or used on more than one person. There have been reports, in the literature and other public sources, of the transmission of bloodborne pathogens (such as Hepatitis B, Hepatitis C, and HIV) from unsafe injection practices, and of the use of propofol vials intended for single use on multiple persons. 5.3 Risks of Pediatric Neurotoxicity Published animal studies demonstrate that the administration of anestheti...

Adverse reactions cross-check#

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adverse reactions

6 ADVERSE REACTIONS The following serious or otherwise important adverse reactions are discussed elsewhere in the labeling: • Hypersensitivity reaction [see Warnings and Precautions ( 5.1 )] • Hypotension and/or bradycardia [see Warnings and Precautions ( 5.4 )] • Propofol Infusion Syndrome [see Warnings and Precautions ( 5.9 )] In the description below, rates of the more common events represent U.S/Canadian clinical study results. Less frequent events are also derived from publications and marketing experience in over 8 million patients; there are insufficient data to support an accurate estimate of their incidence rates. These studies were conducted using a variety of premedicants, varying lengths of surgical/diagnostic procedures, and various other anesthetic/sedative agents. Most adverse events were mild and transient. 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 rates in the clinical trials of another drug and may not reflect the rates observed in practice. Anesthesia and MAC Sedation in Adults The following estimates of adverse events for propofol include data from clinical trials in general anesthesia/MAC sedation (N=2889 adult patients). The adverse events listed below as probably causally related are those events in which the actual incidence rate in patients treated with propofol was greater than the comparator incidence rate in these trials. Therefore, incidence rates for anesthesia and MAC sedation in adults generally represent estimates of the percentage of clinical trial patients which appeared to have probable causal relationship. The adverse experience profile from reports of 150 patients in the MAC sedation clinical trials is similar to the profile established with propofol during anesthesia (see Table 3 below). During MAC sedation clinical trials, significant respiratory events included cough, upper airway obstruction, apnea, hypoventilation, and dyspnea. Anesthesia in Pediatric Patients Generally, the adverse experience profile from reports of 506 propofol pediatric patients from 6 days through 16 years of age in the U.S/Canadian anesthesia clinical trials is similar to the profile established with propofol during anesthesia in adults. Although not reported as an adverse event in clinical t...

adverse reactions table

Anesthesia/MAC SedationICU SedationBody as a Whole:Anaphylaxis/Anaphylactoid reaction perinatal disorder, tachycardia, bigeminy, bradycardia, premature ventricular contractions, hemorrhage, ECG abnormal arrhythmia atrial, fever, extremities pain , anticholinergic syndrome, asthenia, awareness, chest pain, extremities pain, fever,increased drug effect, neck rigidity/stiffness, trunk painFever, sepsis, trunkpain, whole body weaknessCardiovascular:Premature atrial contractions Syncope, hypotension [see also Clinical Pharmacology (12)], tachycardia Nodal,arrhythmia Bradycardia, arrhythmia, atrial fibrillation, atrioventricular heart block, bigeminy, bleeding, bundle branch block, cardiac arrest, ECG abnormal, edema, extrasystole, heart block, hypertension, myocardial infarction, myocardial ischemia, premature ventricular contractions, ST segment depression, supraventricular tachycardia, tachycardia, ventricular fibrillationBradycardia, decreased cardiac output, arrhythmia, atrial fibrillation, bigeminy, cardiac arrest, extrasystole, rightheart failure, ventricular tachycardiaCentral Nervous System:Hypertonia/Dystonia, paresthesia, movement, abnormal dreams, agitation, amorous behavior, anxiety, bucking/jerking/thrashing, chills/shivering/clonic/myoclonic movement, combativeness, confusion, delirium, depression, dizziness, emotional lability, euphoria, fatigue, hallucinations, headache, hypotonia, hysteria, insomnia, moaning, neuropathy, opisthotonos, rigidity, seizures, somnolence, tremor, twitchingAgitation, hypotension, hills/shivering, intracranial hypertension, seizures, somnolence, thinking abnormalDigestive:Hypersalivation, nausea, cramping, diarrhea, dry mouth, enlarged parotid, nausea, swallowing, vomitingIleus, liver function abnormalHemic/Lymphatic:Leukocytosis, coagulation disorder, leukocytosisInjection Site:Phlebitis, pruritus, burning/Stinging or pain, hives/itching, phlebitis, redness/discolorationMetabolic/Nutritional:hypomagnesemia, hyperkalemia, hyperlipemiaBUN increased, creatinine increased, dehydration, hyperglycemia, metabolic acidosis, osmolality increased, hyperlipemiaMusculoskeletal:MyalgiaNervous:Dizziness, agitation, chills, somnolenceDeliriumRespiratory:Wheezing, cough, laryngospasm, hypoxia, apnea, bronchospasm, burning in throat,dyspnea, hiccough, hyperventilation, hypoventilation, pharyngitis, sneezing, tachypnea, upper airway o...

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
43598-265Propofol Injectable EmulsionPropofol Injectable EmulsionDr. Reddy's Laboratories, Inc.ANDACurrent
43598-548Propofol Injectable EmulsionPropofol Injectable EmulsionDr. Reddy's Laboratories, Inc.ANDACurrent
43598-549Propofol Injectable EmulsionPropofol Injectable EmulsionDr. Reddy's Laboratories, Inc.ANDACurrent