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Pfizer Inc. said Thursday it has launched a generic version of Celebrex, a painkiller, after receiving a warning from a federal health care provider that it was not approved by the Food and Drug Administration.

Pfizer said the company's generic product, which will be available by prescription only to consumers, will cost the company $65 for the 12.6-milligram dose of Celebrex, compared with $40 for the 12.6-milligram drug, which the company said was available in generic form.

Pfizer said the FDA's decision came after it received an FDA advisory notice that it was not approved by the agency for Celebrex in the first quarter of 2014.

"We are pleased to receive this important information from Pfizer," said David Gold, Pfizer's chief executive officer.

The warning, which will now go to the FDA's Office of Compliance, was part of a government effort to make the drug more widely available, Pfizer said in a statement. The company also said it would "continue to follow up on regulatory actions" regarding Celebrex, including whether it was approved for use in pediatric patients.

Pfizer said that it would "continue to take this matter forward as part of our ongoing efforts to expand our range of products," and that it was working on new product launches that would address its "need to address our existing supply chain challenges and ensure that all Pfizer products meet the stringent standards that our competitors need to achieve."

The drug's safety and effectiveness have been under scrutiny, with some studies linking the drug to heart attacks and strokes and others indicating that Celebrex may have a direct cardioprotective effect on some blood pressure medications, such as some blood pressure drugs.

In January, Pfizer announced that it was reviewing Celebrex for safety and efficacy and that it would be updating all regulatory action on the drug.

Pfizer said it will now have the full regulatory approval and marketing authorization for its Celebrex, the most widely prescribed arthritis painkiller among its class. The company will begin selling the drug at the same time as it conducts clinical trials of Celebrex and other new medicines.

The company's Celebrex, also called celecoxib, was approved by the FDA for the treatment of osteoarthritis and rheumatoid arthritis in 2007. Its first full-year FDA approval came just a few months after Celebrex was rejected by the FDA for safety reasons.

Pfizer, which sells generics, is the largest pharmaceutical company in the world, with more than 2 million prescriptions for nearly 70 million people in more than 100 countries. But the company has said it intends to move forward with its efforts to launch its products.

The company has been promoting Celebrex to U. S. consumers for several years, even though the FDA does not approve it for the treatment of osteoarthritis or rheumatoid arthritis.

Pfizer's Celebrex's U. sales have been down about 10 percent since the FDA's latest warning in January. The company says it's still working on how to improve its safety profile for its products, as well as how to increase awareness of its medicines and their benefits, and how to continue to develop, develop and market its product.

Pfizer also said it is working with pharmaceutical companies and government health authorities to develop a new program that will allow patients to be treated with Celebrex, as well as the prescription version of Celebrex, and other treatments for arthritis.

The Food and Drug Administration's announcement was based on a July 2014 letter to Pfizer that asked regulators to approve the drug for U. patients only if they have approved by the end of the year for Celebrex. Pfizer said that it had not received any warning letters from the FDA. "We also have the opportunity to conduct ongoing studies to evaluate and improve our safety profile and the efficacy and safety of Celebrex," Pfizer said in a statement.

The letter to the FDA asked the company whether it was willing to allow the company to sell Celebrex in the U. without approval, because Pfizer had no authority to do so.

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INTRODUCTION Celebrex 200mg Capsules, a prescription NSAID, is frequently used to manage pain and inflammation, but it also can also be used for other conditions, such as osteoarthritis, rheumatoid arthritis, and menstrual cramps. Celebrex 200mg Capsules are a medication used to treat conditions like osteoarthritis, affecting the menstrual cycle and bones. They work by reducing the production of hormones that cause pain and inflammation, such as ovulation, and by blocking the COX-2 enzyme, which is involved in the production of these hormones. Celebrex 200mg Capsules are taken orally, usually once daily, and are subject to certain safety and efficacy considerations. What are? Celebrex 200mg Capsules are available in a tamoxapine form, meaning that they can be produced in any strength available, without the use of tamoxapine.

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.

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Celebrex 200mg Capsule – Uses In Musculoskeletal & Skin Conditions

Celebrex 200mg capsule is used in the relief of signs and symptoms of rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis. It works by decreasing production of prostaglandins, effectively reducing pain and inflammation. Celebrex 200mg capsule is used for the relief of signs and symptoms of rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis when inflammation is already present. It is also used for the relief of pain and inflammation caused by arthritis in cases of rheumatoid arthritis and in cases of rheumatoid arthritis in adults and adolescents for the relief of painful conditions caused by bacteria or other inflammatory disorders.

Show/full Medical Information

This medication works by reducing inflammation and pain. By reducing pain and inflammation, it helps in easing the burden on your stomach and intestines, making it easier to move about during the day. It also reduces swelling, redness, and redness, which can cause a flare-up. It is also used for the relief of pain and inflammation caused by arthritis in adults and adolescents for the relief of painful conditions caused by bacteria or other inflammatory disorders. The active ingredient in Celebrex 200mg capsule is Celecoxib. Consult your doctor before using this product if you have osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, or any other pain relief challenges. Celebrex 200mg capsule is only for effective relief of signs and symptoms of rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis. It works by decreasing the production of prostaglandins, effectively reducing pain and inflammation. Consult your doctor for more details.

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