Lannett cleared to market Nexium generic

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PHILADELPHIA — Lannett Co. has received Food and Drug Administration approval for 20-mg and 40-mg esomeprazole magnesium delayed-release capsules, an antacid.

Lannett said its esomeprazole product is a generic version of Nexium delayed-release capsules (20 mg and 40 mg), aka “the purple pill,” from AstraZeneca Pharmaceuticals.

A proton pump inhibitor, esomeprazole decreases the amount of acid in the stomach and is used to treat symptoms of gastroesophageal reflux disease (GERD).

Esomeprazole magnesium delayed-release capsules (20 mg and 40 mg) totaled U.S. sales of approximately $1.4 billion for the 12 months through July, according to IMS Health data reported by Lannett.

“The approval for esomeprazole magnesium delayed-release capsules demonstrates our ability to develop high quality, complex formulations,” stated Arthur Bedrosian, chief executive officer of Lannett. “This approval, our seventh thus far in 2017, comes from our wholly owned subsidiary, Kremers Urban Pharmaceuticals. I commend our regulatory, R&D, legal, production, supply chain and staff for this approval of a Paragraph IV product. Our sales team will now begin to utilize their skills, as they always do, to gain market share. A number of competitors are currently marketing the product. We anticipate launching ours in the next several months.”


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