Wyoming MPJE (Pharmacy Jurisprudence) Practice Exam

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Study for the Wyoming MPJE Pharmacist Licensure Exam. Utilize flashcards and multiple choice questions, each with hints and explanations. Prepare thoroughly for your exam!

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When might a drug company submit a SNDA?

When a new drug fails phase 2 trials
When there is a change in marketing strategy
When they discontinue a drug
When they make a new tablet strength, dose form, or indication for their drug

The correct answer is: When a new drug fails phase 2 trials

A drug company might submit a Supplemental New Drug Application (SNDA) when they make a new tablet strength, dose form, or indication for their drug. SNDA is a process through which drug companies can seek approval from the FDA to make changes to an already approved drug. This includes changes such as introducing a new dosage form, changing the strength of the drug, or adding a new indication for use. Therefore, option D is correct. Option A, stating that a drug company would submit a SNDA when a new drug fails phase 2 trials, is incorrect. A failed phase 2 trial for a new drug would typically lead to discontinuation of the development of that particular drug, rather than a submission of an SNDA. Option B, regarding a change in marketing strategy, is not a reason for submitting a SNDA. Changes in marketing strategy would fall under the purview of the drug company's marketing team and not require a SNDA submission. Option C, mentioning the discontinuation of a drug, also does not align with the purpose of a SNDA submission. When a drug is discontinued, it does not usually involve submitting a new application to the FDA.