FDA approves generics from Amneal and Dr Reddy’s, and Natco submits ANDA

Generics/News | Posted 22/03/2019 post-comment0 Post your comment

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.

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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].

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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 

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