Orphan Drug Report

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Orphan Drug Report An orphan drug is a drug designed to treat a rare disease or condition. For a drug to qualify for orphan status both the drug and disease or condition must meet certain criteria specified in the Orphan Drug Act (ODA). This designation would qualify the sponsor of the drug for developmental incentives which includes waiving of regulator fees, faster or simpler clinical trial and approval process, tax credit or grants to offset research and development, and a period of marketing exclusivity which means no competition for many years. it does not mean that the FDA is less strict when it comes to safety and effectiveness. All of this is specified within the FDA’s implementing regulations at 21 CFR Part 316. It’s…show more content…
There are a great many side effects the most common include fear, increased cough, lack or loss of strength, night sweats and throat irritations The primary means of dosage is through intravenous injection and the strength depends on the condition it is being used for. These conditions include non-Hodgkin's Lymphoma, Rheumatoid Arthritis, Chronic Lymphocytic Leukemia, Wegener's Granulomatosus, Microscopic, Polyangiitis. The life threatening side effects of using Rituxan include abnormal heart rhythm and liver damage. Another example is Gleevec from Novartis Oncology this drug went on to have non-orphan indications; it had sales of $2.4 billion in 2010. The brand name of the drug is Gleevec and the generic name is Imatinib. This drug interferes with the growth of some cancer cells. Gleevec is used to treat certain types of leukemia (blood cancer), bone marrow disorders, and skin cancer, or certain tumors of the stomach and digestive system. The most common side effects include Acid or sour stomach, belching, difficulty having a bowel movement (stool), difficulty with moving, discouragement,excess air or gas in the stomach or intestines, fear or nervousness, feeling sad or empty, feeling unusually cold, full or bloated feeling, increased bowel movements, irritability, lack or loss of strength, loose stools, loss of interest or pleasure, muscle stiffness, night sweats, passing gas,
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