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Perrigo Announces FDA Final Approval Of Betamethasone Valerate Foam

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(credit: istock) Technology Report
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ALLEGAN — Perrigo Co. (Nasdaq: PRGO) Tuesday announced that its partner, Cobrek Pharmaceuticals Inc., received final approval from the United States Food and Drug Administration for its Abbreviated New Drug Application for betamethasone valerate foam 0.12 percent, the generic equivalent of Luxiq Foam.

Perrigo has manufactured the product and is preparing to commence commercial shipments on Jan. 15, consistent with the date certain launch settlement.

Cobrek was first to file, making the product eligible for 180 days of marketing exclusivity.

Betamethasone valerate foam 0.12 percent is indicated for the relief of corticosteroid-responsive skin conditions of the scalp (scalp psoriasis). Brand annual sales were approximately $40 million.

“This is our sixth product approval using a foam dosage form, which requires specialized development and manufacturing capabilities,” said Perrigo chairman, president and CEO Joseph C. Papa. “It is an example of the excellent partnership we have with Cobrek and we are committed to making quality healthcare more affordable for our customers and drive value for our shareholders.”

From its beginnings as a packager of generic home remedies in 1887, Perrigo has grown to become a leading global provider of over-the-counter and generic prescription pharmaceuticals, nutritional products and active pharmaceutical ingredients. Perrigo is the world’s largest manufacturer of OTC pharmaceutical products for the store brand market. Perrigo sells primarily in the United States, United Kingdom, Mexico, Israel and Australia, as well as certain other markets throughout the world, including Canada, China and Latin America.

More at www.perrigo.com.

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