Lannett Company Inc. (LCI) said that the U.S. Food and Drug Administration or FDA approved the company's 505(b)(2) New Drug Application or NDA for Morphine Sulfate Oral Solution on June 23, 2011. Sales of Morphine Sulfate Oral Solution for the last 12 months at Average Wholesale prices or AWP were around $31.7 million, according to Wolters Kluwer. The company expects to commence shipping the product shortly.
Bedrosian went on to say that the company is expecting to receive approvals for a number of Abbreviated New Drug Applications or ANDAs now pending at the FDA, and looks forward to working with the agency, both locally and in Maryland, on other 505(b)(2) NDA filings.
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