BTEC3317

Homework 8 – Marketing Approvals

1. Go to https://www.fda.gov/
2. Click on the “Drugs” tab.
3. Find box on “Approvals and Clearances”. Click on “Search Drug Approvals by Month
Using Drugs@FDA”. That should bring you to the “FDA Approved Drug Products”.
4. Click on “Drug Approval Reports by Month”.
5. Choose “Original New Drug Approvals (NDAs and BLAs) by Month”.
6. Below, select your month of birth and year 2017. Click “Search”.
7. Mention your birth month somewhere in your report.
8. From the resulting table, choose one of the drugs approved during your birth month that
has a review classification entry in the 5th column. In your report, mention your drug
name, the NDA or BLA Application number, active ingredient, submission classification,
review priority classification and drug manufacturer. Describe what the review priority
means (Hint:There’s a link somewhere on the same page as your search result.
9. Click on the entry in the 2nd column, “Drug name”, for your chosen drug. That will
bring you to a page with more information about your NDA.
10. Click below on the link that says “Label for NDA ####”. You will have to choose a
different drug if the “Labels for NDA####” is not available for your first choice.
11. In the resulting table, click on Label (PDF). What is the title of the resulting document?
12. For what indication is your drug for?
13. Mention at least one warning and adverse reaction on the use of your drug. Be sure to
define/describe any uncommon medical or scientific word (jargon) that you use.
14. Briefly describe other types of information that are found in the label.
15. Now go to http://clinicaltrials.gov/
16. In the search box for other terms, type the “active ingredient of your drug AND drug
name”, then click “Advance Search”. If no results are found, just search for your drug’s
active ingredient, but click also on advance search.
17. Under “Recruitment Status” select “Completed”.
18. Under “Additional Criteria”, select Phase 3. Then press “search”.
19. Click on the “Study Title” of one of the phase 3 studies that has a status of “Completed”
and “has results”. That should bring you to the details of the trial. It is possible that your
drug was approved after only a phase 2 trial in which case you will be selecting Phase 2
in step 18. Or if there is no completed phase 3, go with a phase 3 that is still
“Recruiting”.
20. Briefly describe the study plan objective, trial design (ppt 08, slide 21) and mention at
least 2 patient inclusion and 2 exclusion criteria. Use Google to explain technical terms
that you may encounter as inclusion/exclusion criteria.
21. Do a Pubmed search on the drug, API, or indication and add other interesting tidbits to
fill up your one page. Just pick 1-2 really good research paper to summarize. Follow the
correct reference citation format.
Drug Report Farxiga

The drug Farxiga which was approved on March 1, 2017 has the NDA number
202293. The main active ingredient in Farxiga are Dapagliflozin propanediol in the
strength of both 5 mg and 10 mg. The final approved label of Farxiga mentions several
different factors that affect patients who use Farxiga. The purpose of Farxiga is to be an
inhibitor along with diet and exercise to improve control over type 2 diabetes mellitus.
The company that applied for this approval is called AstraZeneca AB. Farxiga has some
warning and precautions that include hypotension, ketoacidosis, kidney problems, and
some mycotic infections. The Label then continues to specifically cover the side effects
of Farxiga with regards to their clinical study that allowed for more careful usage of
Farxiga with various patients.
One such example of a clinical trial that was completed showed some significant
results was entitled, “Effects of Dapagliflozin 10 mg on Insulin Resistance in Patients
with Type 2 Diabetes Mellitus (DERISC).” The brief summary of the clinical trial as
chronicled by the organizers of the study was described as, “an 8-week, single centre,
randomized, parallel-group, double-blind, placebo-controlled Phase IV study to evaluate
the effect of dapagliflozin on tissue specific insulin sensitivity in patients with Type 2
diabetes mellitus.” The study went to explain the