GlaxoSmithKline (GSK) announced on December 11th, 2011, that it has received an application from the U. S. Food and Drug Administration (FDA) to approve the generic version of Paxil® (paroxetine), a controlled-release version of the FDA-approved drug, Paxil. Paxil is a selective serotonin reuptake inhibitor (SSRI) antidepressant. The FDA-approved generic drug is indicated for the treatment of major depressive disorder, generalized anxiety disorder, panic disorder, social anxiety disorder, obsessive-compulsive disorder (OCD), and posttraumatic stress disorder.
The application was filed on March 19th, 2011, in the United States. On October 15th, 2011, GSK announced that it had received a letter from GSK to submit a request for a letter of review for the application. On October 26th, 2011, GSK filed a request to issue a decision and an application to be filed with the FDA. In accordance with the terms and conditions of this letter, GSK has submitted a request to the FDA for a letter of review. A copy of the request and letter of review is attached hereto.
GSK will continue to market the drug throughout the rest of 2011 and continues to manufacture and market it. This is the second time in the past ten years that the company has filed a generic application for the drug. A full list of generic products manufactured and distributed by GSK is available.
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Last modified on September 1, 2011Show more about drug informationGSK has provided this information as of September 1, 2011. GSK has provided this information to inform users of its products and services and to inform consumers of the latest and ongoing developments in the pharmaceutical industry. The information on this page does not take the place of careful consideration of the circumstances of the user, and the information should not be relied on as a substitute for the advice of a healthcare professional. The information contained herein should not beSold or used as a substitute for the medical advice of a healthcare professional. Talk to your healthcare professional if you have any questions related to the usage of this information and you are unsure whether the information is appropriate for your needs.
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Product and service descriptions may differ from those described in the press release.
The information contained herein is not an exhaustive review of all antidepressant medications. The information has been provided for purposes of determining whether a particular drug is appropriate for a particular patient, but it is not a complete description of all possible antidepressant medications and is not meant to include all medications or treatments for all patients. The information does not include a guarantee of safety or any assurance of full information contained herein, and it is not intended to provide a complete list of all possible warnings or precautions for any drug. The information does not contain a guarantee or assurance that the drug will work or that the dose, duration, route, quality, dosage form, or route of administration will be adequate or effective in treating any patient. The information does not assure that the antidepressant or any treatment for depression, anxiety, or any other mental illness will be effective or safe in treating any patient. The information does not include a complete list of all possible warnings or precautions for any antidepressant medication.
The information contained herein is not for use in isolation or any part of the medical or mental healthcare of a person in which a drug is prescribed, or to make any drug or medical treatment available to a patient without prior consultation with a healthcare professional, unless expressly stated. It is not intended to be exhaustive or to be used for the medical or mental healthcare of a person in which a drug is prescribed, the medical advice or treatment for a patient is available to a patient without prior consultation with a healthcare professional, or unless they are expressly stated. It should not be relied on as an admission or substitute for the advice of a healthcare professional. If a drug is not being used, it should be referred to by a healthcare professional.
In addition, the company may make any changes to the drug information that it believes are appropriate, but the company does not assume any liability for any aspect of the information contained herein.
Paxil is a medication used to treat depression and anxiety disorders. It is an antidepressant. It works by increasing the levels of certain chemicals in the brain.
Paxil is prescribed to treat various conditions, including depression, panic disorder, and social anxiety disorder. The drug is also used in treatment of other mental health conditions.
Paxil can be taken without a doctor’s prescription. It’s important to note that not everyone will benefit from Paxil. If you have any concerns about your dosage, consult with your doctor or pharmacist for guidance.
Paxil is available in a range of dosage forms, including tablets, oral solutions, and oral capsules. In addition, Paxil is available in different forms, including oral tablets, oral suspensions, and topical creams. Some forms of Paxil may interact with other medications.
Paxil is available in oral suspension form. It is typically taken orally, usually in a single dose of 2.5 to 5 milligrams (mg), taken once a day. It is important to follow the prescribed dosage and not exceed the recommended dose. It is recommended to take Paxil exactly as prescribed by your doctor or pharmacist.
Paxil is available in various dosages, including:
Paxil is a selective serotonin reuptake inhibitor (SSRI) medication. SSRIs work by increasing the levels of serotonin in the brain. By blocking the reabsorption of serotonin, Paxil helps to delay the release of serotonin into the body, increasing the amount of serotonin in the brain. This helps to alleviate anxiety, panic attacks, and other symptoms of depression.
Paxil is a short-acting medication. It can be taken once a day, usually in a single dose of 10 to 20 milligrams (mg). The maximum recommended dose of Paxil is 2.5 mg per day.
Paxil is available in both oral and topical forms. Oral suspensions, creams, and gels, and topical creams, and ointment, cream, and ointment sprays, may be applied directly to the affected area. These topical forms may be applied for a short period of time or only after using the treatment. It is important to note that Paxil can cause dizziness and fainting in some people. If you experience any side effects, such as nausea, dizziness, or headaches, talk to your doctor or pharmacist.
Paxil can be used alone or in combination with other medications. Some antidepressants may be associated with a higher risk of side effects, while some other medications may cause more severe side effects. It is essential to discuss any concerns or side effects with your doctor or pharmacist before starting treatment with Paxil.
Paxil should be taken exactly as prescribed by your doctor or pharmacist. Do not alter your dose or treatment plan without consulting your doctor or pharmacist.
It is important to note that Paxil is not a cure for depression and can only treat symptoms. It is only effective in managing depression and may not work for everyone. It is essential to talk to your doctor or pharmacist about any concerns or questions before starting treatment.
Paxil may be used for other uses; including but not limited to:
Paxil is available in the following forms:
Paxil is available in oral suspension:
Paxil is available in a variety of forms, including tablets, oral suspensions, and topical creams. Tablets may be used for different conditions. For example, Paxil tablets may be used to treat depression or anxiety.
Paxil may also be used in the treatment of an enlarged prostate (benign prostatic hyperplasia or BPH). It is not a cure for BPH, but it can relieve symptoms.benbenbenbenbenbenbenbenbenbenbenbenbenbenbenbenbenbenbenbenbenbenbenbenbenbenbenbenbenbenbenbenbenbenbenbenbenbenbenbenbenbenbenbenbenbenbenbenbenbenbenbenbenbenbenbenbenbenbenbenbenbenben
Paxil may also be used to treat anxiety. It may be used alone or in combination with other medications. It may also be used to treat other conditions. It may also be used to treat the symptoms of an enlarged prostate (benign prostatic hyperplasia).
Paxil may also be used to treat obsessive-compulsive disorder (OCD), including but not limited to:
Obsessive-compulsive disorder (OCD) is a condition where a person feels they are being treated for obsessions or repetitive behaviors.
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Description:Paxil (Paroxetine) is an antidepressant medication that is prescribed to treat major depressive disorder in adults and children over the age of 12. It works by increasing the levels of certain chemicals in the brain, which can improve mood and reduce feelings of anxiety.
Directions for Use:
Warnings:
Ingredients:
Paroxetine hydrochloride, sulfate: C22H19N2O2.
Directions:
The recommended dose is one tablet of 60 mg taken orally once a day.
Storage:
Store at room temperature in a tightly closed container. Keep out of the sight and reach of children. Keep the product out of sight and reach of children.
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Take one tablet as and when needed, with or without food. Do not take more than 1 dose in 24 hours. Avoid if you have heart disease, high blood pressure, a history of stroke or blood clots. Do not take it more often than every 4 hours or as directed by your doctor. The maximum dose should not be more than 8 capsules per day. Take it on an empty stomach, with a meal or snack. Do not lie down for at least 1 to 3 hours after taking a dose.
The most common side effects of Paxil include nausea, vomiting, constipation, diarrhea, dry mouth, loss of appetite, weakness, headache, dizziness, weakness, headache, sweating, and fatigue. Less common side effects may include dry mouth, dizziness, constipation, blurred vision, dry mouth, skin rash, skin rash, dizziness, nausea, stomach pain, increased heart rate, and feeling anxious or nervous. Contact your doctor immediately if any of these side effects persist.
Do not start taking Paxil within 1 hour of taking a dose. If you become pregnant while taking Paxil, call your doctor. Your doctor will monitor you closely during treatment. Do not discontinue Paxil or take other medications without consulting your doctor.
Some drugs may interact with Paxil.
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