AR 2007 Lo Res.pdf
Jolessa is the generic version of the SEASONALE ® extended- cycle oral contraceptive and was launched in September, following a competitor's approval and launch of its own generic SEASONALE product. In July, the Company launched its SEASONIQUE ® (levonorgestrel/ ethinyl estradiol tablets 0.15 mg/ 0.03 mg and ethinyl estradiol ...
AR 2007 Lo Res.pdf page 14
233040 Seasonale
The risks associated with taking oral contraceptives increase significantly if you: Rx only (levonorgestrel / ethinyl estradiol tablets) 0.15 mg / 0.03 mg (levonorgestrel / ethinyl estradiol tablets) 0.15 mg / 0.03 mg (levonorgestrel / ethinyl estradiol tablets) 0.15 mg / 0.03 mg (levonorgestrel / ethinyl estradiol ...
author: Mary
233040 Seasonale page 2
author: Mary
233040 Seasonale page 1
author: Mary
Pages
Under the SEASONALE extended regimen, women take active contraceptive tablets of 0.15 mg of levonorgestrel/ 0.03 mg of ethinyl estradiol for 84 consecutive days, followed by a sevenday interval during which placebo pills are taken to induce a withdrawal bleeding period. While the FDA review of the NDA continues, the Company continues planning for a launch...
author: Lisa
Pages page 6
author: Lisa
http://www.paladin-labs.com/pdf_files/2005_10_26.pdf
NEWS RELEASE PALADIN AND DURAMED SIGN SEASONALE PRODUCT CANADIAN LICENSE AND DISTRIBUTION AGREEMENT First Filing for Approval of SEASONALE ® Extended- Cycle Oral Contraceptive Outside of the United States Montreal, Canada, October 26, 2005 Paladin Labs Inc. On September 30, 2005, Paladin filed on behalf of Duramed the New Drug Submission (NDS) for ...
http://www.paladin-labs.com/pdf_files/2005_10_26.pdf page 1
http://www.fda.gov/cder/orange/appendix_a.txt
2, BUTABARBITAL SODIUM SARISOL, BUTABARBITAL SODIUM APPENDIX A PRODUCT NAME INDEX SATRIC, METRONIDAZOLE SCABENE, LINDANE SCANDONEST L, LEVONORDEFRIN SCANDONEST PLAIN, MEPIVACAINE HYDROCHLORIDE SCLEROSOL, TALC SCRUBTEAM SURGICAL SPONGEBRUSH, HEXACHLOROPHENE SEASONALE, ETHINYL ESTRADIOL SECOBARBITAL SODIUM, SECOBARBITAL SODIUM SECONAL SODIUM, SECOBARBITAL SODIUM...
http://www.int-med.uiowa.edu/Intranet/Residents/xToDelete/GMedCurricOld/Jan-Jun%2004/Contraception/UTD-Oral.pdf
Levonorgestrel - containing prel= larations may aggravate these problems, and should be avoided. However, individual women have had been reported to have significant decreases in the plasma concentrations of ethinyl estradjo] when taking certain other antibiotics, such as tetrqs; ys'li~, pbnicillin derivatives, and cephalosporins [1; 1,,; 1,3]. Pills containing less...
author: floerchingerd [ M68498 ]
Prescription and Over-the-Counter Drug Product List: 9/2003
ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; HYDROCODONE BITARTRATE SOLUTION; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN >A> + MIKART 325MG/15ML;7.5MG/15ML N40482 001 SEP 25, 2003 SEP NEWA ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE TABLET; ORAL >A> OXYCODONE AND ACETAMINOPHEN >A> AA WATSON LABS 325MG;7.5MG N40535 001 SEP 05, 2003 SEP NEWA >A> AA 325MG;10MG...
author: AUTHOR
http://www.fda.gov/cder/foi/label/2003/21544_seasonale_lbl.pdf
Table 1: Mean ± SD Pharmacokinetic Parameters Following A Single Dose Administration of Two Tablets of Seasonale in Healthy Female Subjects Under Fasting Conditions Analyte AUCt (mean ± ±± ± SD) Cmax (mean ± ±± ± SD) Tmax (mean ± ±± ± SD) T1/ 2 (mean ± ±± ± SD) Levonorgestrel 60.8 ±...
http://www.fda.gov/cder/foi/label/2003/21544_seasonale_lbl.pdf page 38
http://www.fda.gov/cder/foi/label/2003/21544_seasonale_lbl.pdf page 23
http://www.fda.gov/cder/foi/label/2003/21544_seasonale_lbl.pdf page 21
http://www.fda.gov/cder/foi/label/2003/21544_seasonale_lbl.pdf page 3
http://www.fda.gov/cder/foi/label/2003/21544_seasonale_lbl.pdf page 2
http://www.fda.gov/cder/foi/label/2003/21544_seasonale_lbl.pdf page 1
http://www.fda.gov/cder/foi/appletter/2003/21544ltr.pdf
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Rockville, MD 20857 NDA 21- 544 Barr Laboratories Attention: Christine Mundkur Senior Vice President, Quality and Regulatory Counsel One Bala Plaza Suite 324 Bala Cynwyd, PA 19004- 1401 Dear Ms Mundkur: Please refer to your new drug application (NDA) dated August 5, 2002, submitted under...
http://www.fda.gov/cder/foi/appletter/2003/21544ltr.pdf page 1
July | Hot Topics in Healthcare
- Trouble navigating this site This may change this summer, though, if the Food and Drug Administration (FDA) approves Seasonale, the first extended regimen oral contraceptive Under FDA review at press time, the proposed product, manufactured by Barr Laboratories of Pomona, NY, is designed with 84 continuous days of pills containing 150-mcg levonorgestrel and 30-mcg...
http://www.barrlabs.com/overview/annual/BRL_AR2001.pdf
Ending ViaSpan Transplant 1 Launched Trexall TM Oncology 4 Launched Mylocel TM Oncology 2 Launched SEASONALE TM OC 2 Phase III Sept. Pending FDA approval, SEASONALE could reach consumers as early as the second- half of calendar 2003.SEASONALE would be used by women for up to 84 consecutive days, and then they would have a seven- day placebo interval. In...
http://www.barrlabs.com/overview/annual/BRL_AR2001.pdf page 15
Combination hormonal birth control methods (pills, patch, or ring) - [Medication] - Quest Diagnostics Patient Health Library
Topic Contents - Examples - How It Works - Why It Is Used - How Well It Works - Side Effects - What To Think About - References Combination hormonal birth control methods (pills, patch, or ring) - [Medication] - Quest Diagnostics Patient Health Library Combination hormonal birth control methods (pills, patch, or ring) - [Medication] - Quest Diagnostics Patient Health Library Hormones...