Hyderabad, September 07, 2019: Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, along with its subsidiaries together referred to as “Dr. Reddy’s”) today announced the launch ofBupropion HydrochlorideExtended-ReleaseTablets, USP (SR),a therapeutically equivalent generic version ofZyban® (Bupropion Hydrochloride) Extended-ReleaseTablets, approved by the U.S. Food and Drug Administration (USFDA).
The Zyban®brandand generic had U.S. sales of approximately $5.4million MAT for the most recent twelve months ending in June 2019 according to IQVIA Health*.
Dr. Reddy’s Bupropion Hydrochloride Extended-Release Tablets, USP (SR)are available as 150 mg dosage strength in bottle count sizes of 60.
| WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
SUICIDALITY AND ANTIDEPRESSANT DRUGS Although bupropion hydrochloride extended-release tablets (SR) is not indicated for treatment of depression, it contains the same active ingredient as the antidepressant medications WELLBUTRIN®, WELLBUTRIN® SR, and WELLBUTRIN XL®. Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term trials. These trials did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in subjects over age 24; there was a reduction in risk with antidepressant use in subjects aged 65 and older [see Warnings and Precautions]. 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]. |
Please click here for full prescribing information including boxed warnings.
Zyban® is a trademark of GSK group of companies.
*IQVIA Retail and Non-Retail MAT June2019.
RDY-0819-262
Corporate Comm India (CCI Newswire)
