FDA approval for schizophrenia and HIV generics from Zydus Cadila and Lupin

Genéricos/Novedades | Posted 21/06/2021 post-comment0 Post your comment

On 27 May 2021, Zydus Cadila received US Food and Drug Administration (FDA) approval to market fluphenazine hydrochloride tablets which is used to treat schizophrenia and other types of mental condition. On 7 June 2021, Lupin Ltd received approval for emtricitabine and tenofovir disoproxil fumarate tablets which are used in combination with other antiretroviral agents for the treatment of HIV. 

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Zydus Cadila’s fluphenazine hydrochloride is a neuroleptic drug and will be available as 1 mg, 2.5 mg, 5 mg, and 10 mg tablets. These will be manufactured at the company’s plant in Ahmedabad, India.

Lupin’s emtricitabine and tenofovir disoproxil fumarate will be available as 200 mg and 300 mg tablets. These are a generic equivalent of Gilead Sciences, Inc’s Truvada tablets. In addition to the treatment of HIV-1 infections, the tablets are also used for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infections. Lupin’s tablets will join other generic versions of the product on the US market, which was opened for Teva Pharmaceutical’s Truvada generic in 2020 [1]. They will be manufactured at Lupin’s facility in Nagpur, India.

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1. GaBI Online - Generics and Biosimilars Initiative. Gilead’s Truvada will face generics competition in 2020 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jun 21]. Available from: www.gabionline.net/Generics/General/Gilead-s-Truvada-will-face-generics-competition-in-2020 

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