The Company received approval of an ANDA from the FDA for this product, which will be marketed and distributed by Upsher-Smith.
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[28-November-2017] |
MAPLE GROVE, Minn., Nov. 28, 2017 /PRNewswire/ -- Upsher-Smith today announced the launch of KLOR-CON® Powder (Potassium Chloride) for oral solution, 20 mEq. The Company received approval of an abbreviated new drug application (ANDA) from the U.S. Food and Drug Administration (FDA) for this product, which will be marketed and distributed by Upsher-Smith. Sandoz, Inc. will continue as the licensed marketer and distributor in the U.S. for the balance of the KLOR-CON® line of potassium products. The potassium chloride powder market had U.S. sales of approximately $98 million for the 12 months ending September, 2017 according to IMS Health. “The past six months have been particularly exciting for Upsher-Smith as we have transitioned from a privately-owned company to an integral part of the Sawai Group, a globally driven, publicly traded Japanese Company,” said Rusty Field, President and CEO of Upsher-Smith. “The ANDA approval of KLOR-CON® Powder along with other recent ANDA approvals demonstrate our commitment to expanding our portfolio of quality, high-value generic products.” Product Information Please refer to the full Prescribing Information for KLOR-CON® Powder at https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=e61a4522-b91d-400a-952c-6f035e4610dd&type=display. You can also visit www.upsher-smith.com or call 1-888-650-3789. You are encouraged to report suspected adverse reactions to Upsher-Smith Laboratories, LLC at 1-855-899-9180 or to the FDA by visiting http://www.fda.gov/medwatch. KLOR-CON is a registered trademark of Upsher-Smith Laboratories, LLC. About Upsher-Smith View original content with multimedia:http://www.prnewswire.com/news-releases/upsher-smith-launches-klor-con-powder-potassium-chloride-for-oral-solution-300562574.html SOURCE Upsher-Smith Laboratories, LLC |