CHARLESTON, S.C.--(BUSINESS WIRE)--Insert as second sentence after Reference underneath ella® Important Safety Information paragraph: For Full Prescribing Information, please go to: http://pharma.afaxys.com/afaxys/assets/pdf/ella_FPI.pdf.
The corrected release reads:
AFAXYS PHARMACEUTICALS ANNOUNCES LAUNCH OF ECONTRA™ EZ, ITS FIRST OVER-THE-COUNTER EMERGENCY CONTRACEPTIVE
Afaxys now leads the industry by offering the widest array of emergency contraceptive options
Afaxys Pharmaceuticals, a division of Afaxys, Inc., today announced the nationwide launch of EContra™ EZ (Levonorgestrel 1.5 mg), Afaxys’ first over-the-counter emergency contraceptive offered to the public health sector. EContra EZ is a single tablet taken orally and works by delaying or preventing ovulation. The emergency contraceptive can be used up to 72 hours after unprotected sex or suspected contraceptive failure but is more effective the sooner it is taken.
EContra EZ is the sixth drug and the second emergency contraceptive to join Afaxys’ portfolio of FDA-approved and branded generic oral and emergency contraceptive products. With the launch of EContra EZ, Afaxys is now the only U.S. pharmaceutical company to offer both over-the-counter and prescription emergency contraceptives. Last year, Afaxys launched ella® (ulipristal acetate), a prescription progesterone agonist/antagonist emergency contraceptive that is effective at delaying or preventing ovulation for up to five days after unprotected sex or birth control failure.
“Women need an emergency contraceptive they can depend on,” said Ronda Dean, president and CEO of Afaxys. “At Afaxys, as experts in emergency contraceptives, we understand how intimidating and confusing the process can be. EContra EZ is safe and effective and easy to use and is readily accessed through the public health sector without a prescription, giving control to women at a time when they desire it most.”
Afaxys is dedicated to ensuring all women have access to safe, high quality and affordable contraceptive products. As a company focused solely on women’s contraceptives, its main goal is to ease fears and empower women with information to help them better understand and navigate the process.
EContra EZ is now widely available to women who obtain their women’s health products through the public health sector which includes Planned Parenthood, family planning clinics, and Student Health Centers at colleges and universities. The product is also available for women to order directly from KwikMed by visiting www.kwikmed.com or calling 1-877-594-5633.
Pharmacists can order EContra EZ through the following drug distributors:
|Distributor||Web Address||Phone Number||Order Number|
|Anda, Inc.||1-800-331-2632, ext. 7422||501490|
For more information on EContra EZ and Afaxys’ FDA-approved generic and branded oral contraceptive products, please visit pharma.afaxys.com.
ella® Important Safety Information
The most common side effects of ella (ulipristal acetate)tablets include headache (18%), abdominal pain (12%), nausea (12%), dysmenorrheal (9%), fatigue (6%), and dizziness (5%). ella is contraindicated in women with a known or suspected pregnancy, and should not replace a regular method of contraception. Repeated use of ella within the same menstrual cycle is not recommended. ella is not indicated for termination of an existing pregnancy. Women who become pregnant or complain of lower abdominal pain after taking ella should be evaluated for ectopic pregnancy. ella may alter the next expected menses. If menses is delayed beyond 1 week, pregnancy should be ruled out. A rapid return of fertility is likely following treatment with ella, therefore, routine contraception should be continued or initiated as soon as possible to ensure ongoing prevention of pregnancy. ella does not protect against STI/HIV.
Reference: ella® prescribing information. Charleston, SC: Afaxys, Inc. 2014. For Full Prescribing Information, please go to: http://pharma.afaxys.com/afaxys/assets/pdf/ella_FPI.pdf.
Afaxys Disclosure Notice
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 forward-looking statements to reflect subsequent developments.
Afaxys, Inc. is a mission driven, socially conscious business enterprise dedicated to serving the women’s healthcare needs of public health providers and their patients. An emerging leader in the public health sector, Afaxys manages the supply needs of public health providers, ensuring customers receive affordable, reliable access to the products and services they need to care for patients. Since 2005, Afaxys has operated a Group Purchasing Organization, which negotiates favorable pricing across a broad base of healthcare products and services so its customers have access to best-in-class suppliers and service providers. In 2013, Afaxys launched its pharmaceutical division, Afaxys Pharmaceuticals bringing a strong portfolio of quality FDA-approved branded and generic oral contraceptives to the public health sector. The Company has an expanding portfolio of quality FDA-approved pharmaceuticals, which are available mostly through the public health sector including public health clinics, college and university health centers, community health centers, non-retail prescribers, as well as city, county, state and federal facilities, at prices intended to be consistently lower than those currently on the market. To learn more, visit www.afaxys.com.