HEALTH

New Lo Loestrin Fe gets FDA approval

BY Alaric DeArment

ARDEE, Ireland The Food and Drug Administration has approved a new contraceptive from Warner Chilcott, the drug maker said Friday.

 

The company said it plans to launch Lo Loestrin Fe (norethindrone acetate and ethinyl estradiol tablets, ethinyl estradiol tablets and ferrous fumarate tablets) early next year. The company said the contraceptive contains the lowest dosage of estrogen — 10 micrograms — of any oral contraceptive currently available in the U.S. market.

 

 

“We are excited about the approval of Lo Loestrin Fe, which complements our women’s healthcare franchise and expands the product offerings in our branded oral contraceptive portfolio,” president and CEO Roger Boissonneault said in a statement.

 

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HEALTH

Report: FDA may consider strengthening generic drug regulations

BY Alaric DeArment

BETHESDA, Md. The Food and Drug Administration could decide that some generic drugs are not equivalent to their branded counterparts, according to published reports.

 

Bloomberg reported FDA Center for Drug Evaluation and Research director Janet Woodcock as saying in an interview that the agency was considering strengthening regulations on some generic drugs because some did not appear to work as well as the branded versions, based on statements from some patients and generic drug company employees. Woodcock had just given a speech at a technical conference organized by the FDA and the Generic Pharmaceutical Association.

 

 

In 2008, controversy arose amid anecdotal reports that patients taking generic drugs for epilepsy had experienced breakthrough seizures that they had not experienced while taking the branded versions of the drugs. That gave rise to the introduction of generic “carve-out” legislation in 35 states that would have placed restrictions on when a generic drug can be used, though only three of them passed.

 

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Centrum invites women to ‘take back’ time

BY Allison Cerra

MADISON, N.J. Multivitamin maker Centrum is encouraging women to pledge an hour toward an activity that is important to them.

According to a recent Centrum survey, 3-out-of-4 women don’t have enough time in the day to do everything they would like. In response to this, Centrum has launched a new website, LoveFeelingHealthy.com, which gives women the opportunity to win prizes that allow them "take back" time to do something they love. The site also offers users the ability to download a coupon for $3 off their next purchase of Centrum Women’s or Centrum Men’s vitamins to help achieve better health and energy to enjoy life. The promotion is in line with daylight saving time, which occurs on Nov. 7.

"Our survey shows that women’s lifestyles are suffering from lack of energy and time. We know that it’s important for women to live healthy and well-balanced lifestyles so they can do all the activities on their to-do lists," said Tiffany McLaud, franchise lead for dietary supplements at Pfizer Consumer Healthcare, maker of Centrum. "Centrum, along with a healthy lifestyle, can help women find the energy to enjoy life to the fullest."

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