Pfizer Inc. said Tuesday it will begin selling its schizophrenia drug Zyprexa by way of a generic-billing subsidiary, Teva Pharmaceutical Industries Ltd. Teva, the world’s largest generic drug maker, announced Wednesday it has licensed its first-mover company to market an in-process research and development company called Teva Pharmaceuticals, a move that could potentially allow for the production of Zyprexa, a first-mover drug for the treatment of schizophrenia.
The move to Teva represents a significant milestone for Pfizer, whose patent for Zyprexa expires in the United States in April. Teva has since sought to market an in-process research and development company, which would then take the drug off the market for generic versions. The company has no plans to launch generic versions of the drug in the United States. However, in its statement, Pfizer said, “We continue to believe that Zyprexa would be a safe and effective treatment for schizophrenia and bipolar disorder in adults.”
The company said Teva is an “unregulated, third-party business” that has no U. S. or international rights. Pfizer had no comment on the move.
Teva’s chief executive, Ian Read, said in a statement that the drug’s in-process research and development company would be a “strong family business with strong financial and management resources.”
The company also said that it will “continue to work closely with regulatory authorities and the public to monitor and address regulatory challenges associated with the manufacture and sale of the drug.”
Pfizer, which began selling the drug in September, is based in New York and has more than 2,500 employees worldwide. The company has not publicly disclosed the company’s financial status.
The company previously posted annual sales of approximately $4.5 billion for the fiscal year ended December 31, 2017. Its U. sales were $5.6 billion.
Zyprexa, also known as olanzapine, is a type of antipsychotic drug that is used to treat schizophrenia and bipolar disorder. It is also prescribed to reduce manic and depressive episodes of bipolar disorder. Zyprexa is available in generic form and is not approved by the U. Food and Drug Administration for the treatment of schizophrenia.
The company said it would continue to market its product until Teva has fully realized its goal of bringing the drug off the market. The company had hoped to market the drug in the United States by the end of 2016.
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Zyprexa is used to treat schizophrenia, bipolar disorder, and major depressive disorder and is also used to treat manic episodes associated with bipolar I disorder in patients who have not responded to lithium or other mood stabilizers. Zyprexa may also be used for purposes not listed in this medication guide.
Dosage and Administration
Zyprexa should be taken at the lowest dose (250 mg) or in the original bottle (500 mg). Ask your doctor or pharmacist if you can take this medicine more than once every day. You may take it with or without food, but it is important to take it at the same time each day.
The dosage may vary depending on the patient and the condition being treated. For example, the initial dosage for bipolar I disorder is 2.5 to 5 mg per day for six to 12 weeks. If the patient is taking lithium or other mood stabilizers, the initial dosage for bipolar disorder is 5 to 10 mg per day for six to 12 weeks. The maximum recommended dosage is 10 mg per day. The maximum recommended daily dosage is one tablet per day.
Zyprexa may also be given with food. If the patient is unable to swallow the tablet with food, the dose may be increased to a maximum of 2.5 to 5 mg per day. Alternatively, the dose can be increased to a maximum of 5 mg per day.
This medication is available without a prescription. Check the for a complete list of supplements or medications that you may be taking. Take all of this with your most recent prescription or you may have a withdrawal reaction if your suddenly stops taking the medication.
Missed Dose
Zyprexa should be taken only when the patient is unable to take it or unable to take it with the correct dosage. If the patient is taking multiple medications (e.g., lithium, amitriptyline, clonazepam, imipramine, tetrabenazine, buspirone, quetiapine, ziprasidone), missing doses do not take them all at once. The missed dose will not result in the desired outcome.
Storage
Store Zyprexa at room temperature, between 15°C and 30°C (59°F and 86°F). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Zyprexa out of the reach of children and away from children 6 and older.
Zyprexa may be stored at room temperature between 15°C and 30°C (59°F and 86°F). The temperature will only increase with higher concentrations (e.g., 250°C to 500°C).
Severity of Effect
Patients who take Zyprexa may have worsening of their schizophrenia symptoms. Patients who are stable on lithium or other mood stabilizers should be monitored for worsening.
Patients who take Zyprexa for manic episodes associated with bipolar I disorder should be monitored for manic episodes associated with bipolar I disorder. Patients who experience episodes of mania or are severely depressed should stop Zyprexa treatment and contact their doctor. The risk of bipolar I disorder worsening depends on the specific condition being treated. In the absence of a proven benefit, patients should be used as an alternative to lithium or other mood stabilizers.
Precautions
Use with caution in patients with severe cardiac disease or hypotension. This medication may cause a serious drop in blood pressure that may be fatal. Do not use on patients with a history of dizziness, fainting, or lightheadedness due to dizziness or fainting. Use with caution in patients with a history of seizures, recent history of blood clotting, and in patients who are on hemodialysis. Before using Zyprexa, inform your doctor of any previous history of heart attack or stroke or the use of other medications in the past 14 days. Zyprexa may also increase the risk of developing blood clots. Use caution when driving, operating hazardous machinery, or engaging in other hazardous activity activities because the effects of Zyprexa may be increased by Zyprexa use.
ReferencesBriggs GG, Freeman R..”Zyprexa.”GlaxoSmithKline, London, 2000.
Further informationAlways consult your healthcare provider to ensure the information displayed on this page is correct. You should also consult your doctor for more information.
A study published in the journalNeuropsychopharmacologyshows that the antipsychotic medication Zyprexa® (olanzapine) may be effective in the treatment of psychosis in patients with bipolar disorder. In this trial, a group of patients with bipolar I disorder were switched from Zyprexa® (olanzapine) to an antidepressant in a random order. Patients were treated with placebo for 3 months before switching from Zyprexa® to an antidepressant. After stopping the medication, patients were discharged home with their first medication. At the time of the trial, Zyprexa® and an antidepressant were well tolerated.
A total of 1,093 patients with bipolar I disorder treated with an antidepressant were re-evaluated for the following: mean age was 60.5 years (range 19-89 years), mean height was 12.8 cm (range 9-23 cm), and mean weight was 6.9 kg (range 3.7-11.9 kg). The mean duration of illness was 7.5 months (range 0-16 months).
The primary outcome measure was the number of new diagnoses of bipolar disorder based on the Hamilton Depression Rating Scale (HDRS).
A total of 1,003 patients were treated with an antidepressant (placebo) before randomization. In the 3 months follow-up period, 662 new diagnoses of bipolar disorder were identified, of which 272 were new bipolar disorder (95.7% CI 46.2% to 77.7%). The majority of patients with new bipolar disorder were female (77.3%), with a prevalence rate for female sex ratio of 4.4 (95% CI 2.1% to 9.0%).
The mean number of hospitalizations and length of hospital stay for new bipolar disorder were 7.2 days (95% CI 4.5% to 14.8) and 6.4 days (95% CI 5.2% to 14.3), respectively. In the same time period, new bipolar disorder was more frequently reported (46.3% vs. 26.7%).
The mean number of deaths in patients with new bipolar disorder was 1.8 days (95% CI 1.0% to 2.2).
The mean number of hospitalizations and length of hospital stay for patients with bipolar disorder were 5.8 days (95% CI 3.9% to 8.6) and 9.6 days (95% CI 4.6% to 14.5), respectively. In the same time period, patients with new bipolar disorder were more likely to be hospitalized for suicide-related deaths (23.9% vs. 8.6%, 95% CI 2.7% to 15.3).
Patients with bipolar disorder who were hospitalized for suicide-related deaths were more likely to be discharged home with their first medication (34.2% vs. 13.5%, 95% CI 4.8% to 21.1%) than those who were discharged with their second medication (34.2% vs. 13.5%, 95% CI 4.8% to 21.1%, respectively).
The mean duration of hospitalization and discharge for patients with bipolar disorder was 10.6 days (95% CI 4.9% to 14.1).
The mean number of inpatient hospitalizations and length of inpatient stay were 12.1 days (95% CI 3.2% to 21.9) and 2.6 days (95% CI 1.4% to 4.3), respectively. The mean number of inpatient stays and hospitalizations were 9.7 days (95% CI 4.6% to 14.0) and 2.3 days (95% CI 1.8% to 4.0), respectively. There were no differences in the rates of hospitalization for suicide-related deaths among patients with bipolar disorder who were hospitalized for inpatient and discharge (95% CI 1.6% to 0.1%).
The mean number of death in patients with bipolar disorder was 9.6 days (95% CI 3.3% to 16.1).
The mean number of death in patients with bipolar disorder who were discharged home with their first medication was 8.7 days (95% CI 4.1% to 16.4).
The mean time to first depressive episode was 5.8 days (95% CI 3.5% to 7.0).
The mean time to first depressive episode was 3.8 days (95% CI 2.5% to 5.2).
The number of new episodes in patients with bipolar disorder was 12.8 (95% CI 3.4% to 16.6).
EUROPEAN DEBACCOPATIENT INFORMATION
SUMMARY:The use of ZYPREXA has shown to have the following results:
WARNING:ZYPREXA may cause drowsiness, dizziness, tiredness, weakness, and drowsiness. Patients should be alert for these symptoms. Patients should not drive, operate machinery, or perform other potentially dangerous activities until the drowsiness and dizziness have stopped.
The following are drug-related adverse effects of ZYPREXA:
* The product images are for reference only. Generic equivalents may also be supplied by alternate manufacturers.
Zyprexa is an antipsychotic medication used to treat schizophrenia and bipolar disorder. Zyprexa works by blocking the reabsorption of calcium and magnesium in the brain. This helps to balance the levels of neurotransmitters such as dopamine and norepinephrine in the brain, helping to improve symptoms of schizophrenia and bipolar disorder.
Zyprexa comes in a form of oral tablets, and is available in various strengths and forms. Zyprexa is available in an extended-release tablet form that should be swallowed whole, while extended-release tablets should not be chewed or crushed. Zyprexa is usually taken once daily, with or without food.
Zyprexa is typically given as an oral tablet, and is available in multiple strengths. Zyprexa is usually prescribed in the morning and evening, with or without food, as prescribed by a healthcare professional. Olanzapine, when taken as prescribed, can help to ease the symptoms of schizophrenia and bipolar disorder. Zyprexa can also be used as an adjunct to medication therapy to help manage symptoms of depression and anxiety. Zyprexa is usually taken once daily in the morning, with or without food.
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