The purpose of a NDA is to provide enough information to permit the FDA to reach the following key decisions.
Roflumilast represents the first in a new class of agents to treat COPD and, if approved, would be the first oral anti-inflammatory maintenance treatment for the disease.
Annual reports that manufacturers submit to the FDA on approved drugs and biologics, biologic product deviation reports, reports of complications of blood transfusion and collection confirmed to be fatal, and certain reports on human cells, tissues and ce
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Side effects may also lead to non-compliance with prescribed treatment. When side effects of a drug or medication are severe, the dosage may be adjusted or a second medication may be prescribed.
Food and Drug Administration announced today that it is reviewing adverse event reports of liver injury in patients taking the weight loss drug orlistat, marketed as the prescription drug Xenical and the over-the-counter medication Alli.
GSK regularly communicates with independent regulatory bodies and provides them with comprehensive safety data on our products.
Breathing becomes severely compromised and patients may need to be admitted to a hospital.
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