| | MAPLE GROVE, Minn., March 27, 2019 /PRNewswire/ -- Upsher-Smith Laboratories, LLC (Upsher-Smith) today announced the launch of Fluoxetine Tablets, USP, 10 and 20 mg. Upsher-Smith’s product is AB-rated to the branded product, Prozac® (fluoxetine) tablets, USP*. The 10 and 20 mg fluoxetine tablet market had U.S. sales of approximately $69 million for the 12 months ending December 2018 according to IQVIA. Product Information | Product | Strength | NDC # | Package Size | | Fluoxetine Tablets, USP | 10 mg | 0832-0402-30 | 30-count bottle | | Fluoxetine Tablets, USP | 10 mg | 0832-0402-11 | 100-count bottle | | Fluoxetine Tablets, USP | 20 mg | 0832-0403-30 | 30-count bottle | | Fluoxetine Tablets, USP | 20 mg | 0832-0403-11 | 100-count bottle | For questions about ordering, please call Upsher-Smith at 1-800-654-2299. | WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
See full prescribing information for complete boxed warning.
| | - Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a reduction in risk with antidepressant use in patients aged 65 and older.
- In patients of all ages who are started on antidepressant therapy, monitor closely for worsening and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber.
- Fluoxetine is not approved for use in children less than 7 years of age.
| | When using fluoxetine and olanzapine in combination, also refer to Boxed Warning section of the package insert for Symbyax®. | Please refer to the full Prescribing Information, including Boxed Warning for Fluoxetine Tablets, USP here. You can also call 1-888-650-3789 to obtain a copy of the full Prescribing Information.
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. About Upsher-Smith
Upsher-Smith Laboratories, LLC is a trusted U.S. pharmaceutical company that strives to improve the health and lives of patients through an unwavering commitment to high-quality products and sustainable growth. Since 1919, it has brought generics and brands to a wide array of customers backed by an attentive level of service, strong industry relationships, and dedication to uninterrupted supply. As Upsher-Smith celebrates its 100-year anniversary, the company enters a new ambitious era that has been accelerated by its 2017 acquisition by Sawai Pharmaceutical Co., Ltd. Upsher-Smith and Sawai plan to leverage each other for growth worldwide and embark on an exciting new chapter as they seek to deliver the best value for their stakeholders, and most importantly, do more good™ for the patients they serve. For more information, visit www.upsher-smith.com. *Prozac is a registered trademark of Eli Lilly and Company. Prozac® (fluoxetine) Tablets have been discontinued. 114017.01  View original content to download multimedia:http://www.prnewswire.com/news-releases/upsher-smith-launches-generic-version-of-prozac-fluoxetine-tablets-300819476.html
SOURCE Upsher-Smith Laboratories, LLC | |
