Home / Generics / News / FDA approves generics from Amneal and Dr Reddy’s, and Natco submits ANDA

FDA approves generics from Amneal and Dr Reddy’s, and Natco submits ANDA Posted 22/03/2019

In January 2019, the US Food and Drug Administration (FDA) approved Amneal Pharmaceutical’s (Amneal) generic Exelon patch and Dr Reddy’s Laboratories (Dr Reddy’s) Tosymra nasal spray, and Natco Pharma submitted an abbreviated new drug application (ANDA) to FDA for its Ibrutinab tablets.

US generics manufacturer Amneal announced on 14 January 2019 that it has received FDA approval for a generic version of Exelon patch (rivastigmine transdermal system), in three dosages (4.6 mg/24 hours, 9.5 mg/24 hours, and 13.3 mg/24 hours). The Exelon patch is used for the treatment of Alzheimer’s disease.

India-based generics manufacturer Dr Reddy’s and its US subsidiary, Promius Pharma, LLC, announced on the 28 January 2019 that its sumatriptan nasal spray Tosymra has received FDA approval. Tosymra is indicated for the acute treatment of migraine with or without aura in adults, and is the latest product to join the Promius Pharma acute migraine treatment portfolio.

‘This approval affirms our ability to develop well-differentiated products to meet the unmet needs of patients with migraine and HCPs treating them’, said GV Prasad, Co-Chairman and CEO, Dr Reddy’s. It follows Dr Reddy’s US launch of generic Prilosec (omeprazole delayed-release tablets) late in 2018 [1].

Indian pharmaceutical company Natco Pharma announced on 31 January 2019 that it had submitted an ANDA to FDA for Ibrutinab tablets, proposed generic equivalents to Imbruvica tablets used for treating certain cancers. The ANDA includes the Ibrutinab tablets in the strengths of 140 mg, 280 mg, 420 mg and 560 mg. Natco and its co-development and marketing partner, Alvogen Pine Brook LLC, believe that the ANDA is possibly sole first-to-file based on the ANDA filing dates, and that it may be eligible for 180 days of marketing exclusivity at the time of potential launch. In the US, Pharmacyclics LLC and Janssen Biotech, Inc own and market the Imbruvica brand. This ANDA submission follows Natco and Alvogen’s launch of the first generic equivalent of Tamiflu (oseltamivir phosphate) in the US in 2017 [2].

Related articles
Amneal and Impax combine to create 5th largest US generics company

First generic version of Alzheimer’s patch launched in US

References
1. GaBI Online - Generics and Biosimilars Initiative. Dr Reddy’s launches omeprazole and continues sales of generic Suboxone in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Mar 22]. Available from: www.gabionline.net/Generics/News/Dr-Reddy-s-launches-omeprazole-and-continues-sales-of-generic-Suboxone-in-the-US 
2. GaBI Online - Generics and Biosimilars Initiative. Natco Pharma and Alvogen launch first US Tamiflu generic [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Mar 22]. Available from: www.gabionline.net/Generics/News/Natco-Pharma-and-Alvogen-launch-first-US-Tamiflu-generic 

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.

Copyright – Unless otherwise stated all contents of this website are © 2019 Pro Pharma Communications International. All Rights Reserved.

Comments (0)

Generics News Research General

more

Biosimilars News Research General

more