MDRNA MRNA Stock News FDA Approval

MDRNA, Inc. (MRNA) is out today ( June 9, 2009 ) with FDA approval news below. MRNA stock is up 150% now to $3.90. Discuss MRNA

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MDRNA, Inc. Receives Full FDA Approval of Generic Calcitonin-Salmon Nasal Spray for Osteoporosis

Par Pharmaceutical Companies, Inc. Launches Product

Jun 9, 2009 -- MDRNA, Inc. (NasdaqGM:MRNA) announced today that it has obtained full U.S. Food and Drug Administration (FDA) approval of its Abbreviated New Drug Application (ANDA) for generic calcitonin-salmon nasal spray for the treatment of osteoporosis and that Par Pharmaceutical Companies, Inc. (NYSE:PAR) has launched the product.

Calcitonin-salmon nasal spray, a legacy product developed by MDRNA in the early 2000s, is the generic equivalent of Miacalcin® nasal spray, marketed by Novartis Pharmaceuticals Corporation. U.S. sales of Miacalcin® were approximately $112 million in 2008, according to IMS Health data.

On March 31, 2009, MDRNA and Par entered into an agreement under which Par acquired the Company's Abbreviated New Drug Application (ANDA) for generic calcitonin-salmon nasal spray and the Company's FDA-approved, cGMP manufacturing facility in Hauppauge, New York, for an upfront cash payment and profit sharing on commercial sales for five years.

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