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Mylan launches capecitabine tabs

BY Ryan Chavis

PITTSBURGH — Mylan announced the launch of capecitabine tablets USP in 150-mg and 500-mg dosage strengths. The drug is the generic version of Xeloda tablets from Genentech and is indicated as monotherapy, adjuvant therapy and combination therapy for certain types of breast, colon and colorectal cancers, according to the company.

"The approval of this product, one of a number of key approvals that had been pending with FDA, adds an important product to our broad and growing oncology franchise," said Heather Bresch, Mylan's CEO. "We look forward to bringing a lower cost generic version of this product to patients."

Capecitabine tablets had sales in the United States of approximately $773.8 million for the 12 months ending June 30, 2014, according to IMS Health data.

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Twinlab Consolidation Corp. acquires Twinlab Corp. in strategic, employee-led buyout

BY Michael Johnsen

NEW YORK — Twinlab Consolidation Corp. on Monday announced it has acquired Twinlab Corp. in a strategic, employee-led buyout. 
 
“In a fragmented industry, it is fundamentally difficult to influence outcomes and shepherd change," stated Tom Tolworthy, TCC CEO. "This applies to everything from government regulation to standardized raw material quality to the simple consumer desire for safe and efficacious solutions for their health needs,” he said. “Steeped in the authenticity of natural, clean, organic, good-for-you health solutions, TCC aspires to serve the rapidly growing needs of the health-conscious consumer through proprietary manufacturing, efficacious health solutions built on science, and increased market penetration through focused customer-based distribution.”
 
According to the company, the buyout is designed to inject new life into an existing brand and create new opportunity through the expansion of distribution channels and increased manufacturing capacity. 
 
"Everything that happens in this industry starts with the 6,000 mom-and-pop health food stores," Tolworthy said. "They are the educators – the innovators – and they set the trends that everyone else economizes against. TCC not only wants to move along the curve of those trends, we plan to move the curve."
 
In addition to its namesake brand, Twinlab, established in 1968, TCC also manufactures and sells other brands including the Metabolife line of diet and energy products; Fuel line of sports supplement products; Alvita teas; and Trigosamine joint support products.
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FDA announces approval for Orbactiv

BY Ryan Chavis

SILVER SPRING, Md. — The Food and Drug Administration earlier this week announced approval for Orbactiv (oritavancin), an antibacterial drug used to treat patients with acute bacterial skin and skin structure infections. The drug is administered intravenously.

Orbactiv is the third new antibacterial drug approved by the FDA this year to treat ABSSSI. The agency previously announced approval for Dalvance and Sivextro.

“The approval of several new antibacterial drugs this year demonstrates that we are making progress in increasing the availability of treatment options for patients and physicians,” said Edward Cox, M.D., M.P.H, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research. “However, more work is needed in this area, and the FDA remains a committed partner to help promote the development of antibacterial drugs.”

Orbactiv is marketed by the Medicines Co.

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