FDA approves the approval of two celecoxib generic drugs
2022-12-02 08:07:02
Introduction: The US Food and Drug Administration (FDA) approved the approval of two Celebrex generic drugs at the end of May. Celecoxib is currently the best-selling drug for the treatment of rheumatoid arthritis, osteoarthritis and other conditions.
Teva Pharmaceuticals (Teva) has received 50mg, 100mg, 200mg and 400mg celecoxib capsules for marketing approval and 180 days for 100mg, 200mg and 400mg celecoxib capsules. On the other hand, Mylan also obtained 50mg celecoxib capsules.
Dr. Woodcock, director of the FDA Center for Drug Evaluation and Research (CDER), said, “It is very important to have patients with affordable low-cost chronic drug options. Healthcare professionals and patients don’t have to worry about the safety and effectiveness of this approved generic drug. It is in full compliance with us. Strict standards."
It is reported that the FDA imitation prescription drugs are the same as the brand drugs, and the clinical efficacy and safety are equivalent. Both generic and branded drug manufacturers are required to pass GMP standards.
Celecoxib is a non-steroidal anti-inflammatory drug (NSAID). All NSAIDs have a black-box logo in their prescription data that warns health care professionals and patients about the potential fatal heart attack and stroke risk. Patients at risk for heart disease or heart disease (such as high blood pressure, or long-term use of NSAIDs) are at higher risk. It is also mentioned in the drug label that the clinical use of NSAIDs is associated with a potential risk of life gastrointestinal bleeding.
Celebrex clinical trials have shown that patients with arthritis often report abdominal pain, diarrhea, indigestion, flatulence, swelling of the feet or legs (peripheral edema), accidental injury, dizziness, laryngeal inflammation (pharyngitis), runny nose (rhinitis), nasal passages Adverse reactions such as swelling (sinusitis), upper respiratory tract infection and rash.
Teva Pharmaceuticals (Teva) has received 50mg, 100mg, 200mg and 400mg celecoxib capsules for marketing approval and 180 days for 100mg, 200mg and 400mg celecoxib capsules. On the other hand, Mylan also obtained 50mg celecoxib capsules.
Dr. Woodcock, director of the FDA Center for Drug Evaluation and Research (CDER), said, “It is very important to have patients with affordable low-cost chronic drug options. Healthcare professionals and patients don’t have to worry about the safety and effectiveness of this approved generic drug. It is in full compliance with us. Strict standards."
It is reported that the FDA imitation prescription drugs are the same as the brand drugs, and the clinical efficacy and safety are equivalent. Both generic and branded drug manufacturers are required to pass GMP standards.
Celecoxib is a non-steroidal anti-inflammatory drug (NSAID). All NSAIDs have a black-box logo in their prescription data that warns health care professionals and patients about the potential fatal heart attack and stroke risk. Patients at risk for heart disease or heart disease (such as high blood pressure, or long-term use of NSAIDs) are at higher risk. It is also mentioned in the drug label that the clinical use of NSAIDs is associated with a potential risk of life gastrointestinal bleeding.
Celebrex clinical trials have shown that patients with arthritis often report abdominal pain, diarrhea, indigestion, flatulence, swelling of the feet or legs (peripheral edema), accidental injury, dizziness, laryngeal inflammation (pharyngitis), runny nose (rhinitis), nasal passages Adverse reactions such as swelling (sinusitis), upper respiratory tract infection and rash.
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