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FDA Green Lights Strativa Pharmaceuticals' Nascobal® (Cyanocobalamin, USP) Nasal Spray Single-Use Device


6/11/2014 6:20:05 AM

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Strativa Pharmaceuticals Announces FDA Approval of Nascobal® (Cyanocobalamin, USP) Nasal Spray Single-Use Device

WOODCLIFF LAKE, N.J.
, June 10, 2014 /PRNewswire/ -- Strativa Pharmaceuticals, the branded division of Par Pharmaceutical Companies, Inc., today announced that the U.S. Food and Drug Administration has approved Nascobal® Nasal Spray in a single-use device. Nascobal® is a prescription vitamin B12 supplement administered as one spray, one nostril, once a week. Each single-use device delivers one spray of 500 mcg of cyanocobalamin, USP. Unlike the current multi-use glass bottle with actuator pump, no priming is required with the new single-use device, which delivers a precise dose upon administration. A carton of four single-use devices provides patients with a convenient one month supply of Nascobal®. Nascobal® Nasal Spray is indicated for the maintenance of normal hematologic status in pernicious anemia patients who are in remission following intramuscular vitamin B12 therapy and who have no nervous system involvement. Nascobal® Nasal Spray is also indicated as a supplement for other vitamin B12 deficiencies. Refer to full prescribing information for Indications and Usage at www.nascobal.com

"Unlike the current device, our new Nascobal® single-use device does not require priming, which eliminates product loss. In addition, it permits patients to conveniently receive their dose with one spray per disposable device," said Rick Painter, Senior Vice President, Brand Sales and Marketing. "Strativa remains committed to improving the product experience of the patients who rely upon us," Mr. Painter said.

The new Nascobal® Nasal Spray single-use device requires no assembly and simplifies the tracking of dose administration. The disposable single-use device is hygienic, portable and will replace the currently available multi-use product. It will be available in pharmacies in September. Strativa is continuing the development of new and enhanced versions of Nascobal® in order to better meet the needs of those patients who rely upon the product.

Important Information About Nascobal® Nasal Spray

Nascobal® Nasal Spray is contraindicated in patients with sensitivity to cobalt and/or vitamin B12 or any component of the medication. Patients with pernicious anemia should be instructed that they will require weekly administration of Nascobal® for the rest of their lives. If a patient is not properly maintained with Nascobal® Nasal Spray, intramuscular vitamin B12 is necessary. Vitamin B12 concentrations must be monitored. Patients with early Leber's disease (hereditary optic nerve atrophy) who were treated with vitamin B12 suffered severe and swift optic nerve atrophy. Vitamin B12 deficiency may suppress signs of polycythemia vera. Treatment with vitamin B12 may mask this condition. Hypokalemia and sudden death may occur in severe megaloblastic anemia which is treated intensely with vitamin B12. Side effects thought to be related to Nascobal® are usually mild and include headache, nausea, and rhinitis. Refer to full prescribing information for Warnings and Precautions at www.nascobal.com

About Par Pharmaceutical Companies, Inc.

Par Pharmaceutical Companies, Inc. is a privately held, U.S.-based specialty pharmaceutical company that develops, manufactures and markets high barrier-to-entry generic drugs and niche, innovative proprietary pharmaceuticals through its wholly-owned subsidiary's two operating divisions, Par Pharmaceutical and Strativa Pharmaceuticals. For press release and other company information, visit www.parpharm.com.

About Strativa Pharmaceuticals

Strativa Pharmaceuticals, the proprietary products division of a wholly owned subsidiary of Par Pharmaceutical Companies, Inc., excels at finding, enhancing and bringing to market drugs that make a meaningful difference to patients. For more information about Strativa, visit www.strativapharma.com

SOURCE Par Pharmaceutical Companies, Inc.



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