Warner Chilcott plc

today announced that the United States Food and Drug Administration (FDA) has approved Lo Loestrin Fe (norethindrone acetate and ethinyl estradiol tablets, ethinyl estradiol tablets and ferrous fumarate tablets) for the prevention of pregnancy.

 

Lo Loestrin Fe is a novel oral contraceptive that offers women the lowest dosage of estrogen (10 mcg) 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," said Roger Boissonneault, President and CEO of Warner Chilcott.

 

The Company anticipates the commercial launch of Lo Loestrin Fe in early 2011.

 

About Lo Loestrin Fe

 

Lo Loestrin Fe is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.

 

Important Safety Information

 

Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive ( COC ) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs should not be used by women who are over 35 years of age and smoke.

 

For information on dosage and administration, contraindications, warnings and precautions, adverse reactions, and other important safety and other prescribing information, please see http://www.wcrx.com/pdfs/pi/pi_loloestrinfe.pdf .

 

About Warner Chilcott

 

Warner Chilcott is a leading specialty pharmaceutical company currently focused on the gastroenterology, women's healthcare, dermatology and urology segments of the North American and Western European pharmaceuticals markets. The Company is fully integrated with internal resources dedicated to the development, manufacturing and promotion of its products. WCRX-G.