By Ionsalembic Pharma
Copyright indiatimes
Alembic Pharmaceuticals Ltd on Thursday said it has received a final approval from the US health regulator for its generic version of Paroxetine extended-release tablets indicated for treatment of depression and anxiety. The final approval by the US Food & Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) of Paroxetine extended-release tablets of strengths 25 mg and 37.5 mg, Alembic Pharmaceuticals said in a regulatory filing. The approved ANDA is therapeutically equivalent to the reference listed drug product, Paxil CR extended-release tablets, 25 mg and 37.5 mg, of Apotex Inc, it added.Add as a Reliable and Trusted News Source Add Now!
The Paroxetine extended-release tablets 25 mg and 37.5 mg, are indicated for treatment of major depressive disorder, panic disorder, social anxiety disorder, and premenstrual dysphoric disorder, the company said.(You can now subscribe to our Economic Times WhatsApp channel)
Read More News onAlembic PharmaUSFDAAlembic Pharmaceuticals LtdUS Food & Drug Administrationalembic pharmaceuticalsApotex Incparoxetinedepressionalembic pharmaceuticals ltd
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(You can now subscribe to our Economic Times WhatsApp channel)Read More News onAlembic PharmaUSFDAAlembic Pharmaceuticals LtdUS Food & Drug Administrationalembic pharmaceuticalsApotex Incparoxetinedepressionalembic pharmaceuticals ltd(Catch all the Business News, Breaking News, Budget 2025 Events and Latest News Updates on The Economic Times.) Subscribe to The Economic Times Prime and read the ET ePaper online….moreless
