Healthcare Industry News: U.S. Food and Drug Administration
News Release - October 11, 2017
Upsher-Smith Launches Generic Version Of Aromasin(R) (Exemestane) TabletsMAPLE GROVE, Minn., Oct. 11, 2017 -- (Healthcare Sales & Marketing Network) -- Upsher-Smith Laboratories, LLC. (Upsher-Smith) today announced the launch of Exemestane Tablets, 25 mg. The company recently received U.S. Food and Drug Administration (FDA) approval of its abbreviated new drug application (ANDA) for the product. Exemestane Tablets are equivalent (AB-rated) to the branded product, Aromasin®.*
The exemestane tablet market had U.S. sales of approximately $84 million for the 12 months ending August 31, 2017 according to IMS Health.
"We are pleased to offer physicians and patients a cost-effective alternative to Aromasin®," said Rusty Field, President and CEO of Upsher-Smith. "The addition of Exemestane Tablets supports our Company's ongoing commitment to expanding our product portfolio and making quality, reasonably priced generics available to the most patients possible."
The NDC number for Exemestane Tablets, 25 mg is 0832-0595-30. For questions about ordering, please call Upsher-Smith at 1-800-654-2299.
Please refer to the full Prescribing Information for Exemestane Tablets at https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=f8bd17b4-5289-45bb-8095-de89dc8d39ed&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.
Upsher-Smith Laboratories, LLC is a trusted U.S. pharmaceutical company that has strived to deliver quality, affordable generic medications for nearly a century. In June 2017, Upsher-Smith was acquired by Sawai Pharmaceutical Co., Ltd., a large publicly traded generics company in Japan that had been seeking entry into the U.S. market. Upsher-Smith and Sawai share a strikingly similar family history and hold many of the same cherished goals and values— most importantly, the philosophy of always putting patients first. Upsher-Smith will continue to do those things it does best, which is provide a consistent supply of quality, affordable medications and invest in its historically strong industry relationships. Ultimately, we believe our acquisition by Sawai represents a tremendous opportunity to leverage each company for growth worldwide and embark together on an exciting new chapter in generics. For more information, visit www.upsher-smith.com.
* Aromasin is a registered trademark of Pfizer Inc.
Source: Upsher-Smith Laboratories
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