b. Can a drug or biologic approved for a specific indication be used for a diffe

Question

b. Can a drug or biologic approved for a specific indication be used for a different indication by a US-licensed Physician in the US? Explain your response and include the following in your response

(i) If your response is “Yes”, state the requirements that must be met if you believe that a drug can be legally used for a different indication from what it was approved for and include a supporting primary source reference.

OR

(ii) If your response is “No”, provide a primary source reference that supports your choice.

Explanation / Answer

Yes a drug can be be used for an unapproved indication by a US licensed physician in the US.This is known as of label use of drugs and involves the use of a drug for an indication other than that mentioned in the drug label.

In the United States off label use of FDA approved drugs is legal.FDA approved drugs can be prescribed by an physician for any purpose other than that mentioned in the drug label.However off label merketing of drugs is prohibited and is not legal in the US.

Examples of off label use of drugs are as follows: Minoxidil is used for treatment of hair loss.Doxipin is used for the treatment of severe allergic reactions as it possess antihistamine action.Gabapentin is used for treatment of bipolar disorder and restless leg syndrome.Zoloft is used off label in men suffering from premature ejaculation but is actually an anti depressant.

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