UPSHER-SMITH EXPANDS FLUOXETINE PRODUCT LINE TO INCLUDE AN ORAL SOLUTION

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Jan 26, 2023, 11:31 ET

MAPLE GROVE, Minn., Jan. 26, 2023 /PRNewswire/ -- Upsher-Smith Laboratories, LLC (Upsher-Smith) today announced that it has expanded its fluoxetine product family with the launch of Fluoxetine Oral Solution, USP, 20 mg/5 mL. Upsher-Smith's product is a generic version of the product, Prozac^® (fluoxetine) Oral Solution.*

The fluoxetine oral solution market had U.S. sales of approximately $14.2 million for the 12 months ending November 2022 according to IQVIA.

"We are very excited to lead this calendar year off with the launch of Fluoxetine Oral Solution," said Rich Fisher, President and COO, Upsher-Smith. "Upsher-Smith has many exciting things in store for 2023 including the opening of our world-class manufacturing facility in Maple Grove, MN, and a rich pipeline of high-quality generic products, positioning the Company for both near-term and future growth."

Product Information

Product	Strength	NDC #	Package Size
Fluoxetine Oral Solution, USP	20 mg/5 mL	0832-6032-12	120 mL bottle

For questions about ordering, please call Upsher-Smith at 1-800-654-2299.

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS

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 behaviors with antidepressant use in patients over age 24; there was a reduction in risk with antidepressant use in patients aged 65 and older [see WARNINGS AND PRECAUTIONS (5.1)].
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 [see WARNINGS AND PRECAUTIONS (5.1)].
Fluoxetine is not approved for use in children less than 7 years of age [see WARNINGS AND PRECAUTIONS (5.1) and USE IN SPECIFIC POPULATIONS (8.4)].

Please refer to the full Prescribing Information, including Boxed Warning for Fluoxetine Oral Solution, 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. The company brings brands and generics to a wide array of customers, always backed by its attentive level of service, strong industry relationships, and dedication to uninterrupted supply. For more information, visit www.upsher-smith.com.

*Prozac is a registered trademark of Eli Lilly and Company. Prozac^® (fluoxetine) Oral Solution has been discontinued.

SOURCE Upsher-Smith Laboratories, LLC