Sunday, August 15, 2010

FDA approves new morning-after pill | Philadelphia Inquirer | 08/14/2010

FDA approves new morning-after pill | Philadelphia Inquirer | 08/14/2010: "WASHINGTON - The Food and Drug Administration on Friday approved a new type of morning-after contraceptive that works longer than the current leading drug on the market.

The pill ella from HRA Pharma reduces the chance of pregnancy up to five days after sex. Plan B, the most widely used emergency contraceptive pill, begins losing its ability to prevent pregnancy within three days of having sex.

The FDA approved the drug as a prescription-only birth-control option. The ruling clears the way for U.S. sales of the drug, which is already approved in Europe.

Morristown, N.J.-based Watson Pharmaceuticals will market the drug in the United States under an agreement with HRA. Watson said it will launch the pill in the fourth quarter.

Studies of ella by the manufacturer showed it prevented pregnancies longer and more consistently than Plan B.

In a head-to-head trial between the two drugs, women who took ella had a 1.8 percent chance of becoming pregnant, while women who took Plan B had a 2.6 percent chance. Experts tracked nearly 1,700 women who randomly received one of the two pills within three to five days of having unprotected sex.

Plan B is made by Teva Pharmaceuticals and is also marketed in several generic versions.

Unlike ella, Plan B and other generic versions are available without a prescription for women 17 and older.

Paris-based HRA Pharma did not request over-the-counter status for its drug.

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