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CHARLESTON, S.C. -- Afaxys Pharmaceuticals, a division of Afaxys, Inc., today announced the nationwide availability of oral contraceptive Tarina Fe 1/20 (Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets, 1mg/20mcg/75mg), indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Tarina Fe 1/20 is the fifth drug to join Afaxys' portfolio of FDA-approved branded generic oral and emergency contraceptive products, securing the company's position as a leader focused on women's health in the public health arena.

"Afaxys is very pleased to announce the availability of Tarina Fe 1/20 in response to public health customer requests to broaden its portfolio of contraceptive options for women," said Ronda Dean, president and CEO of Afaxys. "The ongoing growth of the Afaxys product line with Tarina Fe 1/20 proves our commitment to ensuring affordable access to quality reproductive health products for public health providers and the women they serve."

Tarina Fe 1/20 is available exclusively for the public health sector and accessible through Planned Parenthood and colleges and universities nationwide. Pharmacists can order Tarina Fe 1/20 through the following drug distributors:


Distributor Phone Number Order Number
R&S Northeast 1-800-262-7770 012803
Seacoast Medical LLC 1-877-410-0811 500034
Pharmedix 1-800-486-1811  

For more information on Tarina Fe 1/20 and Afaxys' FDA-approved generic and branded oral contraceptive products, please visit pharma.afaxys.com.

Important Safety Information
WARNINGS

Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use oral contraceptives should be strongly advised not to smoke.

Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

INDICATIONS AND USAGE

Tarina Fe 1/20 is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.

CONTRAINDICATIONS
  • Oral contraceptives should not be used in women who currently have the following conditions:
  • Thrombophlebitis or thromboembolic disorders
  • A past history of deep vein thrombophlebitis or thromboembolic disorders
  • Cerebral vascular or coronary artery disease
  • Known or suspected carcinoma of the breast
  • Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia
  • Undiagnosed abnormal genital bleeding
  • Cholestatic jaundice of pregnancy or jaundice with prior pill use
  • Hepatic adenomas or carcinomas
  • Known or suspected pregnancy
RISKS

The use of oral contraceptives is associated with increased risks of several serious conditions including myocardial infarction, thromboembolism, stroke, hepatic neoplasia and gallbladder disease, although the risk of serious morbidity or mortality is very small in healthy women without underlying risk factors. The risk of morbidity and mortality increases significantly in the presence of other underlying risk factors such as hypertension, hyperlipidemias, obesity and diabetes.

SIDE EFFECTS

Most side effects of the pill are not serious. The most common side effects are nausea, vomiting, bleeding between menstrual periods, weight gain, breast tenderness, and difficulty wearing contact lenses. These side effects, especially nausea, vomiting, and breakthrough bleeding may subside within the first three months of use.

DOSAGE AND ADMINISTRATION

To achieve maximum contraceptive effectiveness, Tarina Fe 1/20 should be taken exactly as directed and at intervals not exceeding 24 hours.

Please see accompanying full Prescribing Information or consult DailyMed at http://www.tinyurl.com/tarinafepi.

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.

About Afaxys

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 exclusively 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.