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Lannett’s Morphine Sulfate Oral Solution: 505(b)(2) or 505j?

Lannett Co., Inc. and its subsidiary Cody Laboratories manufacture Morphine Sulfate Immediate Release Concentrated Oral Solution 20mg/mL. Readers will remember that the various manufacturers of morphine solution were the first to receive FDA enforcement letters based on the Agency’s Unapproved Drugs Initiative. Roxane Laboratories filed an NDA for its product which was approved January 25, 2010. Lannett/Cody filed an NDA for its product on February 26, 2010, which, as of today, has not been approved. Since the FDA enforcement action stated that unapproved morphine solution products had to be removed from the market by July 24, 2010, Lannett/Cody filed suit against the FDA on July 21, in an attempt to allow the continued sale of its product.

The legal arguments have been presented well by others (see the FDA Law Blog posting). What I want to discuss herein is whether Lannett can succeed with an NDA; should Lannett have filed an ANDA? The Lannett filing indicates that FDA may be thinking the NDA should have been an ANDA:

I have addressed this situation before in this blog. You cannot have two NDA’s for the same drug product.

This is a situation faced by the many manufacturers of the ‘same’ unapproved drugs who wish to gain approval of their products via a 505(b)(2) NDA. The FDA filing of an NDA is not a public record. Unless the sponsor issues a public announcement, the competition will not know an NDA has been filed. Nor will the competition know precisely the content of the filing — the formula of the drug product and the labeling. Thus, submission of an NDA for an unapproved product carries some risk that another manufacturer’s drug product will be approved first. In this case the first approved product becomes the reference listed drug (RLD) in the Orange Book and the other NDA applicants must go through the ANDA procedure.