Section E - Bringing New Drugs to Market

Question 1

Type P Therapeutic Classification

Answer 1

Major therapeutic gain because no other effective drugs available for treating illness

Question 2

Type S Therapeutic Classification

Answer 2

Drug is similar to other drugs in the market

Question 3

Type 1 Chemical Classification

Answer 3

New molecular structure that my be used for same therapeutic purpose as existing drugs.

Question 4

Type 6 Chemical Classification

Answer 4

New therapeutic indication for drug already approved. Generally increases the sales of a drug on the market.

Question 5

Type AA

Answer 5

Drug as potential to be used with Aids and HIV

Question 6

Type E

Answer 6

Drug for life-threatening or severely debilitating disease.

Question 7

Type F

Answer 7

Drug is placed on hold until submitted data has been further validated

Question 8

Type N

Answer 8

Drug is being considered for non-prescription status

Question 9

Type V

Answer 9

Drug being considered for “orphan drug” status

Question 10

Orphan Drugs

Answer 10

Drugs that wouldn’t be profitable for a company because NDA process would exceed anticipated market sales because the diseases affect a relatively small patient population (<200,000)