ALLEGAN (WWJ) — Perrigo Co. (NYSE: PRGO) Tuesday announced it has received final approval from the U.S. Food and Drug Administration for its abbreviated new drug applications for fluocinolone acetonide scalp oil, 0.01%, the generic equivalent to Derma-Smoothe/FS Scalp Oil, and fluocinolone acetonide topical oil, 0.01%, the generic equivalent to Derma-Smoothe/FS Body Oil.
Perrigo expects to begin shipments of both products next month.
Derma-Smoothe/FS Scalp Oil and Derma-Smoothe/FS® Body Oil are indicated for the topical treatment of atopic dermatitis in adult patients and the topical treatment of moderate to severe atopic dermatitis in pediatric patients 3 months and older for up to 4 weeks. Both products have combined annual sales of approximately $25 million, as measured by Symphony Health Solutions.
Also, Perrigo and Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) announced the launch of the generic equivalent to Temodar (temozolomide). Teva will manufacture, market and distribute the product in the United States and both companies will equally share in the cost and profitability of the product in the U.S. Teva was first to file, making the product eligible for 180 days of marketing exclusivity.
This product is the generic equivalent to Temodar (temozolomide), indicated for the treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and then as maintenance treatment and refractory anaplastic astrocytoma patients who have experienced disease progression on a drug regimen containing nitrosourea and procarbazine. Temodar had annual sales of approximately $423 million in the United States, according to IMS data as of Dec. 31, 2012. The launch of this product provides a quality alternative, making cancer therapy more cost effective for patients who suffer from this devastating cancer.
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) is an Israeli pharmaceutical company, committed to increasing access to high-quality healthcare by developing, producing and marketing affordable generic drugs as well as innovative and specialty pharmaceuticals and active pharmaceutical ingredients. Headquartered in Israel, Teva is the world’s leading generic drug maker, with a global product portfolio of more than 1,000 molecules and a direct presence in about 60 countries. Teva’s branded businesses focus on CNS, oncology, pain, respiratory and women’s health therapeutic areas as well as biologics. Teva currently employs approximately 46,000 people around the world and reached $20.3 billion in net revenues in 2012.
From its beginnings as a packager of generic home remedies in 1887, Allegan-based Perrigo has grown to become a global developer, manufacturers and distributor of over-the-counter and generic prescription pharmaceuticals, infant formulas, nutritional products, animal health products, dietary supplements and active pharmaceutical ingredients. Perrigo is the world’s largest manufacturer of OTC pharmaceutical products for the store brand market. Its primary markets and locations of logistics operations have evolved over the years to include the United States, Israel, Mexico, the United Kingdom, India, China and Australia. More at http://www.perrigo.com.