ePillz.com - New Generics on the Contraceptives Market

New Generics on the Contraceptives Market

September 7, 2006 - Food and Drug Administration –

Levonorgestrel / ethinyl estradiol tablets, a generic equivalent of the Seasonale extended-cycle oral contraceptives, have received the final approval from the United States Food and Drug Administration (FDA) on September 7, states the web-site of FDA Center of Drug Evaluation and Research as well as the official press-release issued by Watson Pharmaceuticals, a producer of the generic version of the popular birth control drugs.

Marketing of the new oral contraceptive with the trade name Quasense will be launched immediately. The new pills are indicated for use as the daily oral contraceptives and are based on two working agents: levonorgestrel 0.15mg and ethinyl estradiol 0.03 mg. Both are forms of natural sex hormones, produced in a woman’s body, a combination of which can prevent ovulation and pregnancy. Besides, these medications are said to regulate menstrual flow, treat acne or other hormone-related diseases.

It is interesting to note, that the approval of the generic form of Seasonale followed the expiration of the Barr's 3-year New Product Exclusivity on September 5, 2006. Barr Pharmaceuticals, Inc with its main subsidiaries Barr Laboratories, Inc. and Duramed Pharmaceuticals, Inc., have been marketing Seasonale since September 05, 2003. For the time being, the company can not reissue their exclusive patent for Seasonale; consequently, the other company received the right to produce the generic form of the medication.

In the meantime, Barr Pharmaceuticals Inc. announced the launch of its own generic form of Seasonale under the trade name Jolessa. Thus, the announcements of two new drugs on the American market of oral contraceptives appeared at the same time.

Both Quasense and Jolessa, as well as their branded equivalent Seasonale, belong to the group of the so-called extended-cycle oral contraceptives, which reduce the frequency of menstruations from 13 to 4 per year along with preventing pregnancy.

In fact, the basic features of Seasonale and its new generic forms are common to other birth control pills taken daily: they contain the same hormones, have very similar safety profiles and ensure the same efficacy rates. The difference is that while the usual birth control pills regimen means taking 1 pill daily for 3 weeks, a woman on the extended-cycle pills will have to take 1 pill daily for as long as 3 months. After the active pills period (21 or 84 days respectively), a woman takes one inactive pill daily for 7-day period. As a result, the amount of menstrual cycles is reduced from usual 13 per year to only 4 per year.

So, for the time being American women are presented with two more options of oral contraceptives. Quasense and Jolessa offer benefits not only of reliable pregnancy prevention, but also of creating a really comfortable regimen for women with only 4 menstruations per year. However, the increased risk to experience side effects with the extended-cycle regimen contraceptives in comparison with ordinary birth control pills should be carefully considered by every woman individually.

Nick

External resources
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Se...
http://ir.watsonpharm.com/phoenix.zhtml?c=65778&p=irol-newsArticle&ID=902897&...
http://www.marketwatch.com/News/Story/Story.aspx?dist=newsfinder&siteid=googl...
http://phx.corporate-ir.net/phoenix.zhtml?c=60908&p=irol-newsArticle&ID=90302...
http://www.seasonale.com/