The levothyroxine spectrum: Bioequivalence and cost considerations

Formulary

Volumn 40, Issue 8, 2005, Pages

  Wertheimer, Albert I ^a   Santella, Thomas M ^b  

^a TEMPLE UNIVERSITY SCHOOL OF PHARMACY   (United States)

^b TEMPLE UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARMOUR; LEVO T; LEVOLET; LEVOTHYROXINE; LEVOTHYROXINE SODIUM; NOVOTHYROX; THYRO TABS; UNITHROID;

BIOEQUIVALENCE; DRUG CLASSIFICATION; DRUG COST; DRUG FORMULATION; DRUG MARKETING; DRUG RESEARCH; HISTORY OF MEDICINE; HUMAN; HYPOTHYROIDISM; REVIEW;

EID: 24044532569     PISSN: 1082801X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (27)

1. Hueston WJ. Treatment of hypothyroidism. American Academy of Family Physicians website. Available at: http://www.aafp.org/afp/20011115/1717.html. Accessed August 2, 2005.
2. NCDHealth. The top 200 prescriptions for 2003 by U.S. sales. Available at: http://www.rxlist.com/ top200_sales_2003.htm. Accessed August 1, 2005.
3. Lurie P. Testimony before FDA public meeting on levothyroxine sodium therapeutic equivalence (HRG Publication #1742). Available at: http://www.citizen.org/publications/release.cfm?ID= 7388. Accessed August 2, 2005.
4. Abbott Laboratories 2004 sales report. Available at: http://abbott.com/ investor/2004annualreport/ financials/16_reviewl.html. Accessed August 2, 2005.
5. Electronic Orange Book. Approved Drug Products with Therapeutic Equivalence Evaluations. US Food and Drug Administration. Available at: http://www.fda.gov/cder/ob/default.htm. Accessed August 2, 2005.
6. US Food and Drug Administration. Center for Drug Evaluation and Research website. Available at: http://www.fda.gov/cder/index.html. Accessed July 25, 2005.
7. CDER Guidance Document. Levothyroxine Sodium Products Enforcement of August 14, 2001-Compliance Date and Submission of New Applications. U.S. Food and Drug Administration. Available at: http://www.fda.gov/cder/ guidance/4647fnl.htm. Accessed August 2, 2005.
8. Letter to Knoll Pharmaceutical Company. US Food and Drug Administration; April 26, 2001; Docket No. 97N-314/CP2.
9. Warning Letter to Forest Laboratories, Inc. US Food and Drug Administration; August 7, 2003 (CIN-03-16736). Available at: http://www.fda.gov/ foi/warning_letters/g4190d.htm. Accessed August 2, 2005.
10. FDA response to Abbott's citizen's petition. US Food and Drug Administration; November 7, 2003.
11. Valenstein E. Blaming the Brain. New York: Free Press; 1998:276-279.
12. Wise, Jackui. Research suppressed for seven years by drug company. BMJ. 1997;314:p1145.
13. Dong BJ, Hauck WW, Bambertoglio JG, et al. Bioequivalence of generic and brand-name levothyroxine products in the treatment of hypothyroidism. JAMA. 1997;277:1205-1213.
14. Landis NT. New community pharmacy foundation to benefit from lawsuits against drug companies. Am J Health Syst Pharm. 1999;56: 1912-1915.
15. Johnson SB. Endogeneous substance bioavailability and bioequivalence: Levothyroxine sodium tablets. US Food and Drug Administration Pharmaceutical Science Advisory Committee; March 13, 2003. Available at: http://www.fda.gov/ ohrms/ dockets/ac/03/slides/3926s2.htm. Accessed August 3, 2005.
16. FDA Enforcement Report index. Available at: http://www.fda.gov/opacom/ enforce.html. Accessed August 2, 2005.
17. Mayor GH, Orlando T, Kurtz NM. Limitations of levothyroxine bioequivalence evaluation: Analysis of an attempted study. Am J Ther. 1995; 2:417-432.
18. CDER Guidance for Industry. Unavailability and Bioequivalence Studies for Orally Administered Drug Products-General Considerations. US Food and Drug Administration. Available at: http://www.fda.gov/cder/guidance/4964dft.htm. Accessed August 2, 2005.
19. Nightingale SM. Therapeutic equivalence of generic drugs. Letter to health practitioners. US Food and Drug Administration; January 28, 1998. Available at: http://www.fda.gov/cder/news/nightgenlett.htm. Accessed August 3, 2005.
20. Abbott concerned about generic versions of Synthroid. Chicago Sun-Times. February 17, 2003.
21. Shamon MJ. If Synthroid is safe and effective, why won't it apply for FDA approval like its competitors? Available at: http://www.mercola.com/ fcgi/pf/2001/apr/11/synthroid.htm. Accessed August 2, 2005.
22. Synthroid, Levoxyl generics clear FDA; Sandoz has broadest line. The Pink Sheet. June 28, 2004.
23. Shamon MJ. Thyroid Experts Speak Out Against FDA's Decision to Approve Generic Levothyroxine. Thyroid Free Newsletter. June 30, 2004.
24. The American Thyroid Association website. ATA, TES, and AACE express disappointment and concern for the health of millions of thyroid patients after FDA announces decision to approve generic substitutes for levothyroxine products. Available at http://www.thyroid.org/professionals/ advocacy/04_06_24_fda.html. Accessed August 2, 2005.
25. Pomper S. Drug rush. Washington Monthly. May 2000:36.
26. The American Thyroid Association website. Singer PA, Baxter JD, Gharib H. ATA continues dialogue with FDA on levothyroxine dose precision and bioequivalence standards. Available at: http://www.thyroid.org/professionals/ advocacy/. Accessed August 2, 2005.
27. First Data Bank. Available at: http://www.first databank.com. Accessed July 25, 2005.