Morning Afterwards Bolus Over The Counter?
Plan B, the alleged morning afterwards pill, is already afresh at issue afore the FDA.
Acting FDA Abettor Andrew von Eschenbach, MD, bygone alleged on the drug's maker to alter its appliance for over-the-counter cachet for the drug.
von Eschenbach adapted the aggregation seek to accomplish it accessible without prescription alone to women 18 and older.
The emergency contraception for women is currently available only by prescription. The FDA angle would not change Plan B's availability to women of all ages by prescription.
Duramed, a accessory of Barr Pharmaceuticals, is the maker of Plan B.
Nearly a year ago, the FDA delayed a accommodation on Plan B's over-the-counter application, citation "novel authoritative issues" about authoritative the drug available to women beneath 17.
At the time, the FDA abettor was Lester Crawford, DVM, PhD, who has since resigned. Senate hearings to affirm von Eschenbach as his almsman are scheduled for today.
Yesterday, the FDA appear it is alive with Duramed to boldness the issue.
"We accept that the adapted age for OTC [over-the-counter] access is 18," wrote von Eschenbach in a letter to Duramed anachronous July 31, 2006.
The letter instructs Duramed to alter its Plan B over-the-counter application with that age brake in mind.
The FDA and Duramed will accommodated "immediately," possibly wrapping up the action "in a amount of weeks," says an FDA account release.
About Plan B
Plan B contains a college dosage of levonorgestrel, an additive aswell begin in prescription birth control pills.
The morning afterwards bolus is taken by aperture afterwards caught sex. It can stop the absolution of an egg from the ovary, anticipate the abutment of agent and egg, or block a fertilized egg from adhering to the womb.
If a fertilized egg implants afore a woman takes Plan B, the biologic will not work, according to accomplishments advice on the FDA's web site.