FDA Approves Doryx Delayed-Release 150 mg Tablets
Warner Chilcott Announces Approval of Doryx Delayed-Release 150 mg Tablets
ST. DAVID'S, Bermuda, Jun 23, 2008 (PrimeNewswire via COMTEX News Network) -- Warner Chilcott Limited announced today that the Food and Drug Administration (FDA) has approved a 150 mg strength of Doryx (doxycycline hyclate) Delayed-Release Tablets.
Doryx Delayed-Release Tablets are a tetracycline-class oral antibiotic indicated for adjunctive treatment of severe acne. Doryx Delayed-Release Tablets contain enteric-coated pellets of doxycycline hyclate which do not release until they reach the small intestine, thereby minimizing the gastrointestinal side effects most commonly associated with other doxycycline products. The introduction of the 150 mg tablet strength to the existing Doryx Delayed-Release Tablets franchise of 100 mg and 75 mg offers greater dosing flexibility.
The Company will continue to offer Doryx in 75 mg and 100 mg strengths.
Important Safety Information about Doryx Delayed-Release Tablets
Doxycycline, like other tetracycline-class antibiotics, can cause fetal harm when administered to a pregnant woman. Tetracycline-class antibiotics used during tooth development (last half of pregnancy, infancy, and childhood to the age of 8 years) may cause permanent discoloration of teeth and should not be used unless other drugs are not likely to be effective or are contraindicated.
Patients should be advised that photosensitivity can occur with tetracycline-class drugs. Clostridium difficile associated diarrhea (CDAD) has been reported with nearly all antibacterial agents and may range from mild diarrhea to fatal colitis. To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, Doryx should be used only as indicated. Oral antibiotics may lessen the effectiveness of birth control pills.
For Full Prescribing Information, please visit www.doryx.com.
Warner Chilcott is a leading specialty pharmaceutical company currently focused on the women's healthcare and dermatology segments of the U.S. pharmaceuticals market. The Company is a fully integrated company with internal resources dedicated to the development, manufacturing and promotion of its products. WCRX-G
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SOURCE: Warner Chilcott Limited
Warner Chilcott Limited
Posted: June 2008