PITTSBURGH, March 30, 2009 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that it has entered into a definitive agreement with Mylan Pharmaceuticals International Inc., a generic drug company, to market Celebrex® (celecoxib) from March 31, 2008. The agreement is contingent on a determination by the U. S. Food and Drug Administration (FDA) that Mylan will be eligible for a 180-day exclusivity period for Celebrex® and Mylan will be granted 180 days of marketing exclusivity for that drug. The Mylan agreement does not alter the exclusivity period provided by the Mylan agreement. The agreement with Mylan will also provide for a 180-day period of marketing exclusivity for Celebrex® from July 1, 2007, to December 31, 2007, with a 180-day period of exclusivity for Mylan's other generic drugs. The Mylan agreement also includes provisions for Mylan's rights to subJECTing other generic pharmaceuticals to Mylan's Celebrex®, and the exclusionary provisions regarding Mylan's rights to subJECTing all generic pharmaceuticals to Celebrex® and Mylan's other generic pharmaceuticals. The Mylan agreement further includes a potential provision for Mylan to exclude other generic pharmaceuticals from the marketing exclusivity period for Celebrex®, which is contingent upon FDA approval of its generic version and Mylan's agreement to the extent that Celebrex® is marketed in the United States. The Mylan agreement does not alter the rights of Mylan to receive a 180-day exclusivity period for Celebrex®. The agreement does not include coverage for Mylan's other generic drugs, including the generic version of Celebrex®, which are non-U. approved generic drugs that are FDA approved, or in the case of a generic drug, Mylan has an agreement to exclude other generic drugs from the marketing exclusivity period. The Mylan agreement does not include coverage for the non-U. approved generic versions of Celebrex® and Mylan's other generic versions of Celebrex®. The agreement does not contain language requiring Mylan to notify FDA of Mylan's status for additional exclusivity if there is a change in marketing exclusivity agreement with a potential Mylan competitor. The Mylan agreement does not include coverage for Mylan's other generic drugs, including the generic version of Celebrex®, which are non-U. approved generic drugs that are FDA approved, or in the case of a generic drug, Mylan has a right to exclude other generic drugs from the marketing exclusivity period for Celebrex®. approved generic drugs that are FDA approved, or in the case of a generic drug, Mylan has a right to exclude other generic drugs from the marketing exclusivity period for Celebrex®, which is contingent upon FDA approval of its generic version. The Mylan agreement does not contain language requiring Mylan to notify FDA of Mylan's status for additional exclusivity if there is a change in marketing exclusivity agreement with a potential Mylan competitor.
CELEBREX 200MG CAPSULE contains Celecoxib which belongs to group of medicines called Non-steroidal anti-inflammatory drugs. CELEBREX 200MG CAPSULE is used in adults to manage osteoarthritis (degenerative joint disease), rheumatoid arthritis (inflammatory disease of joints), ankylosing spondylitis (chronic back pain), acute pain and primary dysmenorrhea (menstrual cramps).
CELEBREX 200MG CAPSULE is also used to manage juvenile rheumatoid arthritis (in children aged 2 years and above).
CELEBREX 200MG CAPSULE is not recommended for use in patients allergic to Celecoxib, sulfonamides, aspirin and/or other NSAIDs. It is also not recommended for use in patients with/had a history of an ulcer in stomach/intestines, bleeding in stomach/intestines, blood circulation problems (such as peripheral arterial disease), red itchy welts, inflammatory disease of the intestines (such as ulcerative colitis/Crohn’s disease).
The medicine is also not indicted for use in patients suffering from lung problems (such as asthma), heart diseases (such as heart failure, recent heart attack, heart block), severe liver disease (such as advanced hepatic insufficiency) and/or kidney disease (such as advanced renal insufficiency).
Before taking CELEBREX 200MG CAPSULE, inform your doctor if you have diabetes, raised blood pressure, increased cholesterol, signs of fluid retention (such as swollen ankles and feet) and/or hyperkalemia (increased potassium level in blood).
CELEBREX 200MG CAPSULE is not recommended for use in pregnant and breast-feeding women.
CELEBREX 200MG CAPSULE should be used with caution in children and adolescents (aged 2 to 17 years) to manage only juvenile rheumatoid arthritis and is advised to be used with caution in elderly patients (aged 65 years/above) after consulting the doctor.
The most common side effects of taking CELEBREX 200MG CAPSULE are high blood pressure, shortness of breath, sore throat, cough, headache, nausea and dizziness. Consult your doctor if any of these symptoms worsen.
How should I take CELEBREX 200MG CAPSULE? CELEBREX 200MG CAPSULE comes in 200 mg as an oral capsule, which is taken once daily.All patients are advised to take 200 mg before intercourse with plenty of water. The dose is dependent on your age, body weight, other medical conditions you may have and/or impaired kidney disorders. Inform your doctor about your all symptoms since they are your chief concern.
CELEBREX 200MG CAPSULE should be taken according to your doctor’s Advice. You should follow the dosage instructions provided by your doctor and not adjust your dosage due to any reason without first speaking with you at your nearest one.
Your doctor’s Warnings:
Take CELEBREX 200MG CAPSULE strictly as itt help your condition. Do not skip any doses and continue with how you are feeling. If you experience symptoms like rash, itching/swelling (especially of the face and throat), poor skin colour, hives, and associated with a rash, seek medical attention immediately.
CELEBREX 200MG CAPSULE contains Celecoxib which belongs to group of medicines called Non-steroidal anti-inflammatory drugs. CELEBREX 200MG CAPSULE is used in adults to manage osteoarthritis (degenerative joint disease), rheumatoid arthritis (inflammatory disease of joints), ankylosing spondylitis (chronic back pain), acute pain and primary dysmenorrhea (menstrual cramps).
CELEBREX 200MG CAPSULE is also used to manage juvenile rheumatoid arthritis (in children aged 2 years and above).
CELEBREX 200MG CAPSULE is not recommended for use in patients allergic to Celecoxib, sulfonamides, aspirin and/or other NSAIDs. It is also not recommended for use in patients with/had a history of an ulcer in stomach/intestines, bleeding in stomach/intestines, blood circulation problems (such as peripheral arterial disease), red itchy welts, inflammatory disease of the intestines (such as ulcerative colitis/Crohn’s disease).
The medicine is also not indicted for use in patients suffering from lung problems (such as asthma), heart diseases (such as heart failure, recent heart attack, heart block), severe liver disease (such as advanced hepatic insufficiency) and/or kidney disease (such as advanced renal insufficiency).
Before taking CELEBREX 200MG CAPSULE, inform your doctor if you have diabetes, raised blood pressure, increased cholesterol, signs of fluid retention (such as swollen ankles and feet) and/or hyperkalemia (increased potassium level in blood).
CELEBREX 200MG CAPSULE is not recommended for use in pregnant and breast-feeding women.
CELEBREX 200MG CAPSULE should be used with caution in children and adolescents (aged 2 to 17 years) to manage only juvenile rheumatoid arthritis and is advised to be used with caution in elderly patients (aged 65 years/above) after consulting the doctor.
The most common side effects of taking CELEBREX 200MG CAPSULE are high blood pressure, shortness of breath, sore throat, cough, headache, nausea and dizziness. Consult your doctor if any of these symptoms worsen.
Appropriate medicineThe following side effects have been reported in association with taking CELEBREX 200MG CAPSULE:
Stomach pain, heartburn, nausea and vomiting>suspected gastrointestinal disorder (GI) like a full stomach, heartburn, and stomach pain. This can be especially true in elderly people (over age 60). The disorder causes a gradual and painful rise in the blood pressure that can often be quite severe. This can be especially evident at the dose level (20 mg/day) or in addition to the dose range (50-arerance). The disorder can be serious if treated already at a too high a dose (800 mg) or if this medicine is taken at high altitudes (2,200 to 3,000 feet) from higher altitudes with little or no food or with a high impact impact (such as magnitude of impact).
Allergic reactions like rash, itching/swelling (especially of the face/tongue/throat), severe vomiting/adenitis committee ( stability serious condition in the past) like severe abdominal/intestinal pain, fever, severe pain in the chest, pain during exertion of daily movement, nausea/vomiting.
Most of these serious side effects occur at the dose levels (20 mg/day) or at the lower dose (400 mg) above.
Celebrex 200mg capsule contains the active ingredient Celecoxib. It belongs to the family known as non-steroidal anti-inflammatory drugs (NSAID), and specifically a sub-group known as cyclooxygenase-2 (COX-2) inhibitors. It is used in adults for the relief of signs and symptoms of rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis. In conditions like rheumatoid arthritis and osteoarthritis, excess production of prostaglandins by your body can lead to pain and inflammation. This medicine works by decreasing the production of prostaglandins, effectively reducing pain and inflammation.
Do not take Celebrex 200mg capsule if you are allergic to Celecoxib or any of its ingredients. Inform your doctor if you had reactions to sulfonamide medicines, suffer from ulcers or bleeding in the stomach or intestines, or experienced adverse reactions to NSAID medications like aspirin. Before starting the treatment, inform your doctor because it is recommended to not take this medicine if you are pregnant or are breastfeeding. Do not take this medicine if you have severe liver or kidney disease, have inflammatory intestinal conditions, or have heart-related issues such as heart failure, heart disease, or circulation problems. Additionally, if you have had surgeries on leg arteries or have a history of blood circulation problems, this medicine usage should be avoided. This contains lactose. If you are sugar intolerant, consult your doctor before using this product. This medicine is for adults only, it is not for use in children.
Inform your doctor about if you have a history of stomach or intestinal ulcers or bleeding (avoid if currently present), are on acetylsalicylic acid or antiplatelet therapies, use blood clotting or corticosteroid medications, or simultaneously use other non-acetylsalicylic NSAIDs like ibuprofen. Report your doctor if you have conditions such as smoking, diabetes, high blood pressure, high cholesterol, compromised heart, liver, or kidney function, fluid retention, dehydration, past severe allergic reactions to medications, ongoing infections, or are over 65 years old. Monitoring may be necessary. Notably, Celebrex 200mg capsule could mask fever or infection signs. Remember, alcohol combined with NSAIDs may increase gastrointestinal risks.
Celecoxib (Celebrex) is a member of a class of medications called COX-2 inhibitors. It is available in a generic form. This medication is for adults only, it is not for use in children. Do not take Celebrex 200mg capsule if you are pregnant or breastfeeding. The safety and effectiveness of Celebrex 200mg capsule in children has not been established. Report with your doctor about the potential risks and benefits of this medication during pregnancy or while you are breastfeeding. Contact your doctor if you are pregnant or planning to become pregnant. It is not recommended for use in children or adolescents under the age of 18 years. Overuse of medications can have negative effects on your child's development. Consult your doctor before using Celebrex 200mg capsule if you are taking certain medications, especially if you have any underlying health conditions, especially if you have had a stroke, heart, liver, or kidney condition or if you are over 65 years old. Regular monitoring of kidney function is recommended before use. Celebrex 200mg capsule can increase the risk of gastrointestinal events such as perforation, bleeding, or ulcers. Report any unusual movements with your doctor immediately. Monitoring of kidney function is recommended.Celecoxib (Celebrex) is a COX-2 inhibitor. It is used for the relief of signs and symptoms of rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis. Do not take Celebrex 200mg capsule if you are using other painkillers, including ibuprofen. Consult your doctor if you have conditions such as stomach ulcers or stomach bleeding (if using Celebrex 200mg capsule), diabetes, high blood pressure, dehydration, or past severe allergic reactions to NSAIDs, aspirin, or other anti-inflammatory medications. Report with your doctor if you have conditions such as stomach ulcers or stomach bleeding (if using Celebrex 200mg capsule), diabetes, high blood pressure, dehydration, or past severe allergic reactions to NSAIDs, aspirin, or other anti-inflammatory medications. Regular monitoring of kidney function is recommended.
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