Eli Lilly and Company (NYSE: LLY) today announced that it has received a request from the U. S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application for Levothyroxine Sodium in the United States, to market Levothyroxine Sodium as an oral drug for the treatment of hypothyroidism. This is the first FDA application for a generic formulation of levothyroxine sodium. This approval is due to the availability of levothyroxine tablets in the United States, and the availability of the generic form of levothyroxine. The launch of Levothyroxine Sodium is expected to bring new sales for Synthroid (T4) in the United States from $2.5 billion in 2016, compared to Synthroid sales of $1.2 billion in 2016. The generic form of levothyroxine is being developed for patients who have a thyroid disorder and those who do not have a thyroid problem. As of April 30, 2016, Synthroid is the only brand-name levothyroxine tablet approved by the FDA for the treatment of hypothyroidism. The generic levothyroxine tablet is manufactured by AstraZeneca Pharmaceuticals Inc. and distributed by Abbott Laboratories.
Eli Lilly and Company (NYSE: LLY) today announced that it has received an application for its Abbreviated New Drug Application (ANDA) for Levothyroxine Sodium in the United States, which is the first generic-type formulation of levothyroxine sodium approved by the FDA. This approval is expected to bring new sales for Synthroid (T4) in the United States from $2.5 billion in 2016, compared to Synthroid sales of $1.2 billion in 2016. As of April 30, 2016, the generic form of levothyroxine sodium is being developed for patients who have a thyroid disorder and those who do not have a thyroid problem. The generic form of levothyroxine sodium is being developed for patients who have a thyroid disorder and those who do not have a thyroid problem. As of April 30, 2016, the generic levothyroxine sodium is the only brand-name levothyroxine tablet approved by the FDA for the treatment of hypothyroidism. As of April 30, 2016, the generic levothyroxine sodium is the only brand-name levothyroxine sodium approved by the FDA for the treatment of hypothyroidism.Synthroid
Generic name:Levothyroxine - tablet
Pronunciation(lee-SYE-ROX-troid)
Brand name(s)Levothroid, Synthroid
Levothyroxine is used to treat several different conditions (such as thyroiditis, hypothyroidism). It is used to treat only the thyroid hormone deficiency states (hypothyroidism). It works by replacing the thyroid hormone that is produced in the thyroid glands (thyroxine) that are not producing enough thyroid hormones. This hormone helps to regulate body temperature and can be helpful in decreasing symptoms of hypothyroidism (such as fatigue, weight gain). It is used for the treatment of certain types of weight gain associated with thyroiditis, including weight loss. In addition to thyroid hormone deficiency, levothyroxine may be used for other treatment uses.
Read the Patient Information Leaflet if available from your pharmacist before you start taking levothyroxine and each time you get a refill. If you have any questions, ask your doctor or pharmacist.
Take this medication by mouth with or without food as directed by your doctor, usually once daily. If stomach upset occurs, you may take this medication twice daily. Because you may need to take this medication more or once daily, please consult your doctor for specific instructions about how to administer to you.
If you are taking the capsule form of this medication, swallow it whole. Do not split, crush or chew the tablets. If you crush the tablet, crush it in a small amount of water to release the capsule. If you crush the capsule, crush it in a small amount of liquid to extract the tablets. Store at room temperature away from heat, light and moisture. Do not store in the bathroom or near the heat.
Unless advised by your doctor, do not use this medication more often or for longer than directed. Do not take the medicine more often than directed. Keep using this medication even if you feel well. Do not try to achieve the best effect by overdosing.
Tell your doctor if your condition does not improve or if it worsens or if it lasts or if you develop new symptoms.
Tell your doctor if your condition does not get better or if it gets worse.
Your symptoms may get worse as you use this drug. To help you remember, your doctor may ask you questions about your daily life and about the medicine you are taking. Do not stop taking this drug and try to contact your doctor right away if you develop new symptoms, such as new or worsening lymph node tenderness or swelling.
Inform your doctor if you have a history of allergies to any other medications, or if you smoke or drink alcohol.
This drug may rarely cause serious problems, including a heart attack or stroke. Call your doctor if you notice any of the following: muscle weakness, cramps, tender breasts, unusual weakness or pain, fever, persistent vomiting or diarrhea, signs of fluid retention, signs of electrolyte imbalance (such as heartburn or stomach pain), signs of liver problems (such as loss of appetite, fever, dark urine, pale stools or pale stools with jaundice or yellow skin or eyes), signs of kidney problems (such as a decreased amount of sodium in the blood, a change in the amount of potassium in the blood, a rapid decrease or loss of appetite), blood in urine or black stools, signs that you have difficulty passing urine or you have nausea or vomiting while you are taking this drug. Symptoms of low sodium levels include weakness, confusion, slurred speech, leg pain, numbness or tingling, yellowing of the skin or eyes, weakness on one side of the body or feeling unwell, worsening muscle or bone pain, dark urine, pale stools, or unexplained fever, yellowing of the skin or eyes, unusual tiredness or weakness.
This drug may cause slow or irregular heart rhythm (QT prolongation). QT prolongation is a serious side effect of this drug. Call your doctor at once if you have a slow or irregular heart rhythm (QT prolongation), palpitations (fast or irregular heartbeat), or any symptoms of a severe and possibly fatal heart attack (such as chest pain, shortness of breath, chest pain that doesn't go away, coughing up blood or a discharge, sudden painful erection).
Synthroid is a medication that contains the active ingredientlevothyroxine, a synthetic nucleoside analogue. It is primarily used to manage hypothyroidism, a common condition in which you have low thyroid hormone levels.
Synthroid is available in tablet form and should be taken orally with a full glass of water. You should follow your dosage and instructions as soon as possible after taking this medication. Your condition will usually improve within a few days of starting treatment. However, your condition may vary based on several factors, including your sex drive, diet, and other lifestyle choices. It is crucial to maintain a healthy lifestyle, including a well-balanced diet and regular exercise, in order to and complete the full course of treatment. Your symptoms may improve within a few days of starting treatment, and your dosage may need to be adjusted. It is important to note that this medication is not a replacement for consulting a doctor for consultation before taking this medication.
Take this medication in the dose and duration as advised by your doctor. Swallow it as a whole. Do not chew, crush or chew this medication. Synthroid may need to be taken with or without food. You may experience colder, longer-lasting effects. Do not take this medication more often than once daily at approximately 4-6 regular intervals throughout the day, every 4 to 6 hours for or, levothyroxine Synthroid, or lithium or divalproex tablets.
The side effects andicities of Synthroid are as follows:
These are not all of the possible side effects of this medication. For a full list, please refer to the prescription information included in the controlled substance information included in the patent.gov website’s information section.
Following the administration of this medication, you may experience the following symptoms:
Certain medications may reduce the effectiveness of this medication.
Synthroid is an FDA-approved synthetic thyroid hormone that is used to treat hypothyroidism and Hashimoto's thyroiditis. It is available in both brand name and generic form. It works by helping to regulate the body's energy levels and increase the amount of energy it produces. It is important to note that Synthroid should only be taken under the guidance of a healthcare professional.
The medication Synthroid is available in both brand name and generic forms. It comes in both brand and generic forms. The medication comes in the form of tablets and oral solution. It is important to note that Synthroid should only be used under the guidance of a healthcare professional. The medication Synthroid is available in is a synthetic form of the thyroid hormone thyroxine (T4). It works by replacing the amount of thyroxine produced by the body. Synthroid is also available in various forms including capsules, tablets, and liquid suspensions. It is also available in both brand name and generic forms. It is important to note that this medication is generally considered safe and effective when used as directed. However, it is essential to consult with a healthcare professional before starting any new medication to ensure it is appropriate for your individual needs.
Synthroid (levothyroxine sodium) is an FDA-approved thyroid hormone that is used to treat hypothyroidism. It is available in both brand and generic form. It is important to note that it is important to follow the dosage and usage instructions provided by your healthcare professional. It is also important to follow the recommended dosage and usage guidelines for Synthroid as prescribed by your doctor.Synthroid should be taken as directed by your healthcare provider. It is generally considered safe and effective when used as directed.
Synthroid (levothyroxine sodium) is an FDA-approved medication used to treat hypothyroidism. It is important to follow the dosage and usage instructions provided by your healthcare professional. It is also important to take Synthroid as directed by your doctor, even if it is not working as effectively as expected.Synthroid (levothyroxine sodium) may not be suitable for everyone. It is important to consult with a healthcare professional before starting Synthroid to ensure it is appropriate for your individual health profile and to discuss any potential side effects or concerns that may arise. It is also essential to weigh the potential risks and benefits of Synthroid against the potential risks and side effects experienced when using it.
Synthroid and thyroid hormone replacement therapies are not the only way to get rid of the symptoms of hypothyroidism. These are also not the only treatment options available for hypothyroidism.
Synthroid and thyroid hormone replacement therapies are not the only treatment options available to get rid of the symptoms of hypothyroidism. They are also not the only treatment options available for patients with certain health conditions.
Hypothyroidism is a condition in which the body's production of hormones is reduced or absent. The symptoms of hypothyroidism can include:
Some of the signs of hypothyroidism can include:
Hypothyroidism can affect many people in different ways.
Hypothyroidism is the result of a condition in which the body's production of thyroid hormones is reduced or absent. It is the result of a condition that causes symptoms of hypothyroidism. Hypothyroidism can affect various people in different ways.
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