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Other Assets
6 Months Ended
Dec. 31, 2012
Other Assets  
Other Assets

Note 8.  Other Assets

 

As of July 24, 2010, Lannett stopped manufacturing and distributing Morphine Sulfate Oral Solution (“MS”).  Lannett filed a 505(b)(2) New Drug Application (“MS NDA”) in February 2010.  Lannett met with the FDA in January 2011 to review the status of the application.  At that time, the FDA stated that it will need to finalize its Establishment Inspection Report for the February 2011 inspection of Lannett’s facilities before it could give final approval on the MS NDA.  The Company received FDA approval in June 2011.  The filing fee related to this application totaled $1,406 and was initially recorded within other current assets on the consolidated balance sheets because the fee was thought to be refundable.

 

In March 2011 and September 2012, the Company had further communications with the FDA regarding the refundable portion of the filing fee.  During December 2012, $584 of the filing fee was returned to the Company.  Of the original $1,406 filing fee, the Company has reclassified $398 to intangible assets and received $584 as a refund from the FDA.  Based on communications with the FDA, the Company continues to believe that the remaining $424 of the filing fee is refundable, and therefore is recorded in other assets on the consolidated balance sheet.

 

The Company’s position has been that the value related to the nonrefundable portion of the filing fee is the cost of getting regulatory approval for its MS product and that this value should be properly recorded as an intangible asset upon approval and shipment of the product.  The intangible asset would then be amortized over the product’s estimated useful life.  As a result of the FDA approval of the MS NDA, an estimate of the nonrefundable amount totaling $398, determined based upon input from a third party analysis, was reclassified to intangible assets upon shipment of the product which commenced in August 2011.  Amortization will be adjusted prospectively, if needed, once the nonrefundable portion of the fee is finalized with the FDA.