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

Generics and biosimilars Initiative

Building trust in cost-effective treatments

Sign up
eng / esp

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

Generics/News | Posted 21/06/2021 0 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.

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.

Teva launches first Truvada and Atripla generics and two digital inhalers

Gilead makes HIV generics deal

LATIN AMERICAN FORUM We are pleased to announce the launch of our brand-new section the ‘Latin American Forum’ on GaBI. Our goal with this new section is to provide you with all the latest news and updates on developments of generic and biosimilar medicines in Latin America in Spanish. Check out the Latin American news articles here! Here is the first article: Precios de los biológicos para la artritis en América Latina Register to receive the GaBI Latin American Forum newsletter. Inform colleagues and friends of this new initiative. LATIN AMERICAN FORUM Nos complace anunciar el lanzamiento de nuestra nueva sección 'Foro Latinoamericano' en GaBI. Nuestro objetivo con esta nueva sección es brindarle las últimas noticias y actualizaciones sobre desarrollos de medicamentos genéricos y biosimilares en América Latina en español. ¡Vea los artículos de noticias latinoamericanos aquí! Aquí está el primer artículo: Precios de los biológicos para la artritis en América Latina Regístrese para recibir el boletín informativo GaBI Latin American Forum. Informe a colegas y amigos sobre esta nueva iniciativa.

Reference
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

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.