Zydus Lifesciences arm bags USFDA okay for Major Depressive Disorder drug Levomilnacipran Extended-Release
Ahmedabad: Zydus Lifesciences Limited’s (formerly known as Cadila Healthcare Limited) subsidiary Zydus Pharmaceuticals (USA) Inc. (Zydus) has received tentative approval from the United States Food and Drug Administration (USFDA) to market Levomilnacipran Extended-Release Capsules, 20 mg, 40 mg, 80 mg, and 120 mg (USRLD: Fetzima Extended-Release Capsules).
Levomilnacipran is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of Major Depressive Disorder (MDD) in adults.
Major depressive disorder (MDD) is a mental disorder characterized by at least two weeks of pervasive low mood, low self-esteem, and loss of interest or pleasure in normally enjoyable activities.
The drug will be manufactured at the group’s formulation manufacturing facility at Moraiya, Ahmedabad, India.
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Levomilnacipran Extended-Release Capsules had annual sales of USD 85 million in the United States according to IQVIA data (IQVIA MAT Sept. 2022).
The group now has 341 approvals and has so far filed over 431* ANDAs since the commencement of the filing process in FY 2003-04.
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Zydus group is headquartered in Ahmedabad, India. The group has manufacturing sites and research facilities spread across five states of Gujarat, Maharashtra, Goa, Himachal Pradesh, and Sikkim in India and in the US and Brazil.
Zydus’ global business has a strong presence in the regulated markets of the US, Europe (France and Spain), and in the high profile markets of Latin America and South Africa. It is also present in a big way in 25 other emerging markets worldwide.
The group has manufacturing capabilities across the entire pharmaceutical value chain: including formulations, APIs, vaccines, biosimilars, complex products (transdermals, topical etc.), animal health products, and wellness products.
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