Drug company asks FDA to approve first ever over-the-counter birth control pill in U.S.

  • 📰 TorontoStar
  • ⏱ Reading Time:
  • 59 sec. here
  • 2 min. at publisher
  • 📊 Quality Score:
  • News: 27%
  • Publisher: 55%

Sverige Nyheter Nyheter

Sverige Senaste nytt,Sverige Rubriker

HRA Pharma’s application sets up a high-stakes decision for health regulators amid legal and political battles over women’s reproductive health.

WASHINGTON—For the first time, a pharmaceutical company has asked for permission to sell a birth control pill over the counter in the U.S.

An FDA approval could come next year and would only apply to HRA’s pill, which would be sold under its original brand name, Opill. The company acquired the decades-old drug from Pfizer in 2014, but it's not currently marketed in the U.S. Many conservative groups stress they are only interested in curtailing abortion, and state bans often explicitly exclude contraception.

In each case, companies must show that consumers can understand the drug's labeling, evaluate its risks and use it safely and effectively without professional supervision. HRA spent seven years conducting the FDA-required studies, including a trial that followed 1,000 women taking its pill for six months.

Birth control pills are available without a prescription across much of South America, Asia and Africa. Last year, Paris-based HRA won U.K. approval for the first birth control pill available there without a prescription. But estrogen also accounts for most of the blood clot risk associated with oral contraceptives. FDA's labeling warns against their use in certain women already at risk for heart problems, such as those who smoke and are over 35.

 

Tack för din kommentar. Din kommentar kommer att publiceras efter att ha granskats.

more corruption when will it stop

Vi har sammanfattat den här nyheten så att du kan läsa den snabbt. Om du är intresserad av nyheterna kan du läsa hela texten här. Läs mer:

 /  🏆 60. in SE

Sverige Senaste nytt, Sverige Rubriker

Similar News:Du kan också läsa nyheter som liknar den här som vi har samlat in från andra nyhetskällor.

Drug company asks FDA to approve first ever OTC birth control pill in U.S.The U.S. Supreme Court overturning of abortion rights has shifted the conversation to contraceptives Make birth control free and easy to get.
Källa: nationalpost - 🏆 10. / 80 Läs mer »

Pharmaceutical company seeks U.S. FDA approval for over-the-counter birth control pillHRA Pharma’s application on Monday sets up a high-stakes decision for U.S. health regulators amid legal and political battles over women’s reproductive health Globalists satanic cult desperation to kill babies
Källa: globeandmail - 🏆 5. / 92 Läs mer »