MDRNA, Inc. Receives Full FDA Approval Of Generic Calcitonin-Salmon Nasal Spray For Osteoporosis

Main Category: Bones / Orthopaedics
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 10 Jun 2009 - 0:00 PDT

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MDRNA, Inc. (NASDAQ: MRNA) announced 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.

"We are pleased that generic calcitonin-salmon nasal spray has received full FDA approval and has been launched by Par," stated J. Michael French, President and CEO of MDRNA. "Revenue generated from the sale of calcitonin-salmon by Par will provide us with working capital to help advance our RNAi programs. I thank the team at MDRNA and Par for their superb efforts to bring this product to market."

For additional product information, please visit http://www.parpharm.com/products.

Source
MDRNA, Inc.