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This document announces the FDA's determination regarding the sale status of CITANEST injections, stating they were not withdrawn for safety or efficacy reasons, which impacts the approval of abbreviated
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How to fill out determination that citanest prilocaine
How to fill out Determination That CITANEST (Prilocaine Hydrochloride) Injection, 1%, 2%, and 3%, and CITANEST PLAIN (Prilocaine Hydrochloride) Injection, 4%, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
01
Gather all required documentation regarding the safety and effectiveness of CITANEST injections.
02
Review the clinical studies and data that support the use of CITANEST (Prilocaine Hydrochloride) and CITANEST PLAIN.
03
Complete the application form provided by the relevant regulatory authority accurately.
04
Attach a detailed statement explaining the reasons why the product was not withdrawn from the market.
05
Include all necessary signatures and approvals where required.
06
Submit the completed application along with supporting documents to the regulatory agency.
07
Keep a copy of the submission for your records.
Who needs Determination That CITANEST (Prilocaine Hydrochloride) Injection, 1%, 2%, and 3%, and CITANEST PLAIN (Prilocaine Hydrochloride) Injection, 4%, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness?
01
Healthcare professionals who administer local anesthetics.
02
Pharmaceutical companies involved in the production or marketing of CITANEST.
03
Regulatory agencies that oversee drug safety and efficacy.
04
Patients who require local anesthesia for medical procedures.
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People Also Ask about
What is another name for Citanest?
Citanest Plain Dental Generic Name: prilocaine hydrochloride injection. Brand Name: Citanest Plain Dental. Drug Class: Local Anesthetics, Amides, Local Anesthetics, Dental.
What is the second name for prilocaine?
LIDOCAINE; PRILOCAINE (LYE doe kane; PRIL oh kane) is a topical anesthetic that causes loss of feeling in the skin and surrounding tissues. It is used to numb the skin before procedures or injections. This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.
How long does prilocaine injection last?
Prilocaine has a fast onset and a medium duration of action. The 2% solution will last up to 4 hours with peripheral nerve blocks. When used in concentrations of 1%, there is less effect on motor nerve fibres and the duration of action is shorter.
What is Citanest plain used for?
4% Citanest Plain Dental Injection is indicated for the production of local anesthesia in dentistry by nerve block or infiltration techniques.
What is the onset time for Citanest?
4.2 Dose and method of administration 3% Citanest® DENTAL with Octapressin® has a rapid onset of action after infiltration anaesthesia, with an average of 2-3 minutes. Inferior alveolar nerve block requires 5 minutes or more to take full effect.
What is the strongest dental local anesthetic?
Bupivacaine 0.5% contains a 1:200,000 concentration of epinephrine and is considered the strongest of all amide anesthetics. It is recommended when local anesthesia is required for longer time periods (90 minutes or longer) and when post-operative pain is expected.
Is prilocaine a Citanest?
4% Citanest Plain Dental (prilocaine HCI Injection, USP), is a sterile, non-pyrogenic isotonic solution that contains a local anesthetic agent and is administered parenterally by injection.
Is Citanest the same as Prilocaine?
Prilocaine (/ˈpraɪləˌkeɪn/) is a local anesthetic of the amino amide type first prepared by Claes Tegner and Nils Löfgren. In its injectable form (trade name Citanest), it is often used in dentistry.
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What is Determination That CITANEST (Prilocaine Hydrochloride) Injection, 1%, 2%, and 3%, and CITANEST PLAIN (Prilocaine Hydrochloride) Injection, 4%, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness?
The determination is a formal statement indicating that CITANEST (Prilocaine Hydrochloride) Injections have not been withdrawn from sale for safety or effectiveness issues, ensuring their availability for medical use.
Who is required to file Determination That CITANEST (Prilocaine Hydrochloride) Injection, 1%, 2%, and 3%, and CITANEST PLAIN (Prilocaine Hydrochloride) Injection, 4%, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness?
The manufacturer or authorized distributor of CITANEST (Prilocaine Hydrochloride) Injection products is required to file this determination.
How to fill out Determination That CITANEST (Prilocaine Hydrochloride) Injection, 1%, 2%, and 3%, and CITANEST PLAIN (Prilocaine Hydrochloride) Injection, 4%, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness?
To fill out the determination, one must provide required information such as product details, justification for the determination, and any relevant supporting documents.
What is the purpose of Determination That CITANEST (Prilocaine Hydrochloride) Injection, 1%, 2%, and 3%, and CITANEST PLAIN (Prilocaine Hydrochloride) Injection, 4%, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness?
The purpose is to officially confirm that these products remain safe and effective for use, thus facilitating their continued marketing and availability.
What information must be reported on Determination That CITANEST (Prilocaine Hydrochloride) Injection, 1%, 2%, and 3%, and CITANEST PLAIN (Prilocaine Hydrochloride) Injection, 4%, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness?
The report must include product identification, reasons for the determination, any safety or effectiveness data, and supporting documentation as required by regulatory agencies.
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