HYDERABAD, Sept 5: Dr Reddy’s Laboratories Limited on Thursday announced the launch of Bupropion Hydrochloride Extended-Release Tablets, USP (SR), a therapeutically equivalent generic version of Zyban? (Bupropion Hydrochloride) Extended-Release Tablets in the US market.
The tablets which are available in 150 mg dosage, was approved by the U.S. Food and Drug Administration (USFDA), Hyderabad-based Pharmaceutical company said in a release here.
The Zyban? brand and generic had U.S. sales of approximately $5.4 million MAT for the most recent twelve months ending in June 2019 according to IQVIA Health
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?.
Anti-depressants 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 behaviour with anti-depressant use in subjects over age 24; there was a reduction in risk with anti-depressant use in subjects aged 65 and older (see Warnings and Precautions).
In patients of all ages who are started on anti-depressant 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].
Zyban? is a trademark of GSK group of companies.
(UNI)
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