NEWS!
SOURCE: Duramed Pharmaceuticals, Inc.
Duramed Receives Approval for Aviane(TM), the First AB Rated Low-Dose Levonorgestrel and Ethinyl Estradiol Oral Contraceptive
- Aviane(TM) to Access Growing Brand Market of $130 Million - - Company's Hormone Line Expands to Meet Lower Dosage Strength Needs in Female Healthcare -
CINCINNATI, May 1 /PRNewswire/ -- Duramed Pharmaceuticals, Inc. (Nasdaq: DRMD - news) announced today that the U.S. Food and Drug Administration (FDA) has approved its Abbreviated New Drug Application (ANDA) for Aviane-28 Tablets (Levonorgestrel and Ethinyl Estradiol Tablets USP, 100 mcg and 20 mcg, respectively). Aviane(TM) is therapeutically equivalent to Alesse(TM)(1). The company plans to commence shipping Aviane in early May.
Aviane is the first and only generic product deemed bioequivalent to and therapeutically interchangeable with Alesse for all new and refill prescriptions. According to IMS data for drugstore and non-retail purchases, Alesse sales in 2000 were approximately $130 million, up 35 percent from 1999.
``This key new product strengthens our position in the oral contraceptive market and brings our hormone family to six products,'' said Duramed's president and chief operating officer Jeffrey T. Arington. ``We are excited that Aviane provides women a low-dose birth control option. There is no lower dose combination of levonorgestrel and ethinyl estradiol than Aviane marketed in the United States.''
Aviane is Duramed's second entry into the $2 billion oral contraceptive market. Apri® (desogestrel and ethinyl estradiol) Tablets, the company's first oral contraceptive, is the desogestrel and ethinyl estradiol market leader-capturing more than 40 percent of the total prescriptions in the segment in which it competes and more than 3 percent of the entire oral contraceptive market since its launch in the fourth quarter of 1999. Duramed has three additional oral contraceptive ANDAs on file with the FDA and is committed to growing this hormone franchise with more products.
Arington continued, ``With the success of Apri, we have proven that we can be very effective in penetrating the oral contraceptive market. Like Apri, Aviane has first-to-file status, and it is the first approved generic of its kind and presently has no other generic competitors. And also like Apri, we will be marketing Aviane as a value brand, meaning that the product can be written as a prescription by physicians and/or substituted for the brand product by pharmacists.
``Aviane is an important addition to the marketplace. Scientific research has focused on continuing efforts to reduce oral contraceptive dosing in order to minimize potential side effects while also assuring effective contraception-Aviane provides such an option at a substantially lower price. Aviane is a precisely formulated AB-rated generic for Alesse, designed to provide patients and healthcare providers with the identical benefits they expect from the brand product while reducing healthcare costs. We anticipate Aviane to be well received by patients, physicians, and pharmacists.
``Duramed is proud to add Aviane to our growing family of women's healthcare products. With our oral contraceptives, Apri and Aviane, and with our estrogen replacement therapy product, Cenestin® (synthetic conjugated estrogens, A) Tablets, the company has enhanced its position as a premier supplier of solid oral dose hormone products.'' |
