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Amneal starts rollout of lidocaine product line

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BRIDGEWATER, N.J — Amneal Pharmaceuticals LLC has begun shipping lidocaine 5% ointment to lead off the launch of a new lidocaine product line.

Amneal said late Tuesday that its lidocaine 5% ointment is available in a 35.44-g tube with child-resistant cap and in a 50-g jar. The white, scent-free topical is now available via wholesalers, distributors and directly to the trade.

Plans call for the company to launch a transdermal patch formulation upon final Food and Drug Administration approval.

“Lidocaine ointment is our third topical medication and, once approved, the patch will be our first transdermal product,” stated Jim Luce, executive vice president of sales and marketing at Amneal. “These two additions to our portfolio demonstrate our commitment to expand into new, more complex dosage forms valued by our pharmacy customers and their patients.”

A local anesthetic topical medication, lidocaine is used to alleviate pain or discomfort caused by skin irritations and minor cuts, scratches or burns. Lidocaine topical is also used to treat rectal discomfort caused by hemorrhoids.

U.S. sales of lidocaine ointment totaled $251 million through September 2015, and lidocaine patch sales were $907 million for the same time period, according to data IMS Health reported by Amneal.


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