Get the free Citizen Petition for Fluoxetine Tablets - fda

This document is a formal petition submitted by Lachman Consultant Services, Inc. to the Food and Drug Administration (FDA) requesting approval for an Abbreviated New Drug Application (ANDA) for Fluoxetine

How to fill out citizen petition for fluoxetine

How to fill out Citizen Petition for Fluoxetine Tablets

1. Gather necessary information about Fluoxetine Tablets, including dosage and usage.
2. Identify the specific reason for the citizen petition, such as seeking FDA review or addressing concerns.
3. Fill out the petition form with accurate information regarding the drug's safety, efficacy, and manufacturing.
4. Include supporting documents, such as clinical study results and adverse event reports.
5. Review the completed petition for any missing information or errors.
6. Submit the petition to the appropriate regulatory body, typically the FDA, following their submission guidelines.

Who needs Citizen Petition for Fluoxetine Tablets?

1. Patients who have experienced adverse effects from Fluoxetine Tablets.
2. Healthcare professionals seeking to address concerns about the drug.
3. Advocacy groups aiming to promote drug safety and efficacy.
4. Anyone interested in influencing regulatory decisions regarding Fluoxetine Tablets.

People Also Ask about

Is fluoxetine legal?

The U.S. Food and Drug Administration (FDA) approved Prozac in 1987. Since then, millions of Americans have taken Prozac. Most patients don't experience serious side effects while taking this medication.

Is fluoxetine a controlled drug?

No, Prozac (fluoxetine) is not classified as a controlled substance by the DEA and does not have physically addictive or abuse properties like an opioid or benzodiazepine. However, as with many medicines, some patients may feel psychologically dependent or experience withdrawal symptoms upon discontinuation.

What age is fluoxetine approved for?

Which antidepressants can children take? Medication*Age (in years)Diagnosis Fluoxetine (Prozac) 8 and older Major depressive disorder 7 and older OCD Fluvoxamine 8 and older OCD Lurasidone (Latuda) 10 and older Bipolar depression6 more rows

What is the available form of fluoxetine?

Fluoxetine is only available in an oral formulation as an oral solution (20 mg/5 mL), tablet (10 mg, 20 mg, 60 mg), capsule (10 mg, 20 mg, 40 mg), and delayed-release capsule (90 mg).

What is the FDA citizen petition?

An FDA citizen petition is a process provided by the United States Food and Drug Administration (FDA) for individuals and community organizations to make requests to the FDA for changes to health policy. It is described in Title 21 of the Code of Federal Regulations (21 CFR Part 10).

Is fluoxetine a restricted drug?

Prozac, or fluoxetine, is a Selective Serotonin Reuptake Inhibitor, also known as an SSRI. Prozac and other SSRIs are not considered narcotics (controlled substances), and the U.S. Drug Enforcement Administration doesn't consider it to have a high risk of addiction or abuse.

Why was fluoxetine taken off the market?

Why was fluoxetine recalled? ing to the FDA, one of the ingredients used to create the fluoxetine 10 mg tablet was not up to the agency's standards. The tablets in these batches, or “lots,” contained an impurity called lactoside, which was not supposed to be in the medication.

What is fluoxetine approved for?

Fluoxetine is used to treat depression, obsessive-compulsive disorder (OCD), bulimia nervosa, premenstrual dysphoric disorder (PMDD), and panic disorder.

Is fluoxetine an illegal drug?

Prozac isn't a controlled substance Mental health medications that are controlled substances include benzodiazepines, which is why it may not be prescribed by your doctor if you have a history of substance abuse or drug addiction. SSRIs such as Prozac, which are very safe medications, are not controlled substances.

Is fluoxetine FDA approved for anxiety?

Like Zoloft, Prozac is an SSRI. It's FDA approved to treat two types of anxiety disorders: panic disorder and social anxiety disorder. It's also approved to treat other mental health conditions, including OCD, MDD, and post-traumatic stress disorder (PTSD).

For pdfFiller’s FAQs

What is Citizen Petition for Fluoxetine Tablets?

A Citizen Petition for Fluoxetine Tablets is a formal request submitted to the FDA or relevant regulatory body, typically seeking a review or action regarding the approval, formulation, or labeling of Fluoxetine Tablets.

Who is required to file Citizen Petition for Fluoxetine Tablets?

Any individual or entity, including manufacturers, healthcare professionals, or consumers, who has a concern related to the safety, efficacy, or labeling of Fluoxetine Tablets may file a Citizen Petition.

How to fill out Citizen Petition for Fluoxetine Tablets?

To fill out a Citizen Petition for Fluoxetine Tablets, one must complete the designated form available from the FDA, providing detailed information about the concern, supporting evidence, and any requested action.

What is the purpose of Citizen Petition for Fluoxetine Tablets?

The purpose of a Citizen Petition for Fluoxetine Tablets is to formally request the FDA to take specific actions such as changing the approval status, modifying labeling, or addressing safety concerns related to the drug.

What information must be reported on Citizen Petition for Fluoxetine Tablets?

Information that must be reported includes the petitioner's details, specific claims or requests, supporting evidence, relevant scientific data, and any previous communications with the FDA regarding the issue.