First emergency contraceptive product hits U.S. market shelves

Contracept Technol Update. 1998 Nov;19(11):141-3.

Abstract

PIP: The Preven Emergency Contraceptive Kit, a product approved by the US Food and Drug Administration (USFDA) for emergency contraception, is now on the market for sale. Produced by Gynetics of Somerville, NJ, the kit consists of an easy-to-use pregnancy test, patient information guide, and 4 blue pills, each containing 0.05 mg ethinyl estradiol and 0.25 mg levonorgestrel. After a woman determines that she is not pregnant by using the kit's test, she takes 2 pills as soon as possible within 72 hours after having unprotected sexual intercourse. The remaining 2 pills are taken 12 hours later. Although Preven is available now only by prescription, Gynetics will cooperate with the USFDA in assessing whether it should be sold over the counter. One course of Preven costs about $20 at a pharmacy, less than any oral contraceptive pills currently used as emergency contraceptives. The Preven Kit carries Health Care Financing Administration approval for Medicaid reimbursement, and most health maintenance organizations have agreed to cover its costs. Two more progestin-only emergency contraceptive products may enter the US market in 1999. Gynetics is in the advanced stages of developing a levonorgestrel-only emergency contraceptive, while Women's Capital Corp. of Seattle, WA, and Washington, DC, plans to submit its application for product approval to the USFDA for a similar progestin-only product by the end of October.

MeSH terms

  • Americas
  • Contraception
  • Contraceptive Agents
  • Contraceptive Agents, Female
  • Contraceptives, Oral, Hormonal
  • Contraceptives, Postcoital*
  • Developed Countries
  • Ethinyl Estradiol*
  • Family Planning Services
  • Government Agencies
  • Health Services Accessibility*
  • Levonorgestrel*
  • North America
  • Organizations
  • United States
  • United States Food and Drug Administration*
  • United States Public Health Service

Substances

  • Contraceptive Agents
  • Contraceptive Agents, Female
  • Contraceptives, Oral, Hormonal
  • Contraceptives, Postcoital
  • Ethinyl Estradiol
  • Levonorgestrel