Generics
FDA Grants Lannett Approval for Generic of Nexium
6 September 2017 - - Philadelphia, Pennsylvania-based generic pharmaceuticals company Lannett Company, Inc. (NYSE: LCI) has received approval of its Abbreviated New Drug Application for Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg and 40 mg, from from the US Food and Drug Administration, the company said.
Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg and 40 mg are the therapeutic equivalent to the reference listed drug, Nexium Delayed-Release Capsules, 20 mg and 40 mg, of AstraZeneca Pharmaceuticals LP. 
For the 12 months ended July 2017, total US sales of Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg and 40 mg, at average wholesale price were roughly USD1.4 bn, according to IMS.
"The approval for Esomeprazole Magnesium Delayed-Release Capsules demonstrates our ability to develop high quality, complex formulations," said Arthur Bedrosian, chief executive officer of Lannett. "This approval, our seventh thus far in 2017, comes from our wholly owned subsidiary, Kremers Urban Pharmaceuticals."
Lannett company, founded in 1942, develops, manufactures, packages, markets and distributes generic pharmaceutical products for a wide range of medical indications.
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