Afaxys Pharmaceuticals Enters Public Health Sector With Its First Generic Oral Contraceptive
Published: Jan 07, 2013
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Afaxys' new oral contraceptive, Chateal, has been approved for use by the public health sector.
WASHINGTON, DC--(Marketwire - January 07, 2013) -
Full Prescribing Information (and boxed warning)
Available only to the public health sector (including family planning clinics, college and university health centers, and city, county, state, and federal facilities), and authorized, non-retail prescribers,
CHATEAL™ \shah*TEEL\ (Levonorgestrel and Ethinyl Estradiol tablets USP, 0.15 mg/0.03mg) is an AB rated, generic contraceptive.
- CHATEAL™ is FDA approved as a generic equivalent to Nordette® and compares to these monophasic regimens: Levora®, Portia®, Altavera®, and Marlissa®
This new Afaxys product is indicated for the prevention of pregnancy in women who elect to use an oral contraceptive for contraception. This product does not protect against the transmission of HIV (AIDS) and other sexually transmitted diseases. The use of oral contraceptives is associated with increased risks of several serious conditions including venous and arterial thrombotic events (such as myocardial infarction, thromboembolism, and stroke), hepatic neoplasm, gall bladder disease and hypertension, although the risk of serious morbidity and mortality is very small in healthy women without underlying risk factors.
Cigarette smoking increases the risk of serious cardiovascular side effects form oral contraceptive use. The risk increases with age and with the extent of smoking (in epidemiologic studies, 15 or more cigarettes were associated with a significant increased risk) and is quite marked in women over 35. Women who use oral contraceptives should be advised not to smoke.
Please see full prescribing information including BOXED WARNING here: http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=8020e9b2-59c0-4417-b0e9-f1a152e919fd.
The approval of CHATEAL™ is an important first step in the Afaxys Pharmaceuticals mission to provide a reliable, affordable supply of contraceptives for women who rely on safety net, family planning clinics, college and university, and city, county, and state providers for their healthcare.
Afaxys Pharmaceuticals is a division of Afaxys, Inc., a company whose core mission is to serve the public health sector with low priced, readily available mission-critical products. Prior to Afaxys Pharmaceuticals' market entry, public health clinics faced unexpected price increases and fluctuating product availability, which made it difficult to plan and deliver services to patients. Afaxys Pharmaceuticals utilizes a 'dual sourcing strategy' which means that if one manufacturer should experience delays or disruptions, Afaxys is able to provide products from another source so it can deliver products to customers when they need them.
Note: This press release was issued in the United States and is intended as reference information for U.S. journalists and customers. The information contained in this Afaxys press release is accurate at the time of issuance, and the company assumes no responsibility for updating the information to reflect subsequent developments.
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