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Teva, Perrigo announce launch of generic temozolomide

BY Jason Owen

JERUSALEM and ALLEGAN, Mich. — Teva Pharmaceutical Industries Ltd., and Perrigo Co. today 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 country. 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 December 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.

Perrigo’s chairman, president and CEO Joseph C. Papa stated, "This first-to-file launch with our partner Teva is another example of our focus to manufacture complex API’s. We are pleased to offer this important product to patients in the United States."

"We are pleased to partner with Perrigo to offer patients a high-quality, less expensive alternative of this important medicine. This launch demonstrates Teva’s commitment to continue to pursue first-to-market opportunities and enhance the value of our portfolio by concentrating on high-margin, low competition markets," stated Allan Oberman, president and CEO of Teva Americas Generics.


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Perrigo announces FDA final approvals for generic equivalents to Derma-Smoothe/FS scalp, body oils

BY Jason Owen

ALLEGAN, Mich. — Perrigo Co. today announced that 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 (fluocinolone acetonide scalp oil, 0.01%) and Derma-Smoothe/FS Body Oil (fluocinolone acetonide topical oil, 0.01%) 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.

Perrigo’s chairman, president and CEO Joseph C. Papa stated, "This is another example of our Rx team’s commitment to launching difficult to manufacture topicals, lotions and foams. We are excited to begin shipments of these products and are dedicated to making quality health care more affordable for all consumers around the globe."

From its beginnings as a packager of generic home remedies in 1887, Allegan, Michigan-based Perrigo Co. has grown to become a leading global provider of quality, affordable healthcare products, the company stated. Perrigo develops, manufactures and distributes over-the-counter and generic prescription pharmaceuticals, infant formulas, nutritional products, animal health, dietary supplements and active pharmaceutical ingredients.


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NASPA event highlights challenges, opportunities

BY Jim Frederick

All the issues and trends impacting retail pharmacy professionals and the industry they serve filter through the 50 state pharmacy associations like currents that feed a larger stream. So the summer meeting of the National Alliance of State Pharmacy Associations served up a laundry list of the most nagging challenges and most promising opportunities facing pharmacy leaders in the coming years, as they confront new reimbursement paradigms, current regulatory hurdles, dramatically new health delivery models and the growing demand for a more patient-centered and more engaged form of pharmacy practice.

Over an uninterrupted, four-and-a-half-hour dialogue Saturday afternoon, dozens of state pharmacy association executives and industry leaders grappled with a wide range of topics that define the challenges and potential facing pharmacy, including:

  • Emerging models of healthcare delivery spurred by health reform and the new evidence-based reimbursement paradigm;
  • Medication adherence and the role that medication synchronization could play;
  • Federal supply chain legislation to establish a nationwide track-and-trace system; and
  • New efforts to establish and document the value of pharmacist interventions and new collaborative-practice models.

The meeting marked a new chapter in the relationship between NASPA and the National Association of Chain Drug Stores, NASPA president Ron Fitzwater indicated. “This is the first time we’ve done this, and we’re looking forward to continuing the relationship in the future. It’s a great opportunity to get state pharmacy associations more formally involved with some very important partners,” Fitzwater said, who is also CEO of the Missouri Pharmacy Association.

 

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