Generics of apixaban and chlorzoxazone approved in EU and US

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Generics of apixaban and chlorzoxazone approved in EU and US

Generics/News | Posted 03/07/2020 0 Post your comment

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended a generic version of the anticoagulant medicine apixaban. Meanwhile in the US, the Food and Drug Administration (FDA) has approved a generic version of the muscle relaxant chlorzoxazone.

Apixaban is a small molecule anti-coagulant used to treat and prevent blood clots and prevent stroke. It was first approved for use in the EU in 2011 and is sold under the brand name Eliquis by Bristol-Myers Squibb/Pfizer.

At the CHMP meeting in May 2020, the Committee recommended approval of a generic version of apixaban developed by Accord, the commercial arm of Intas Pharmaceuticals.

The drug was recommended for ‘treatment and prevention of venous thromboembolic events in adult patients and for the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation’.

FDA has also approved generic versions of apixaban, from the Indian company Micro Labs and US generics giant Mylan [1]. However, these products will not be able to launch on the US market until 2026, when patents on Eliquis expire.

FDA has more recently approved a generic version of the muscle relaxant chlorzoxazone. Chlorzoxazone is used to treat muscle spasm, which can cause extreme discomfort, and works by acting on reflexes in the spinal cord.

The approved generic will be manufactured by the Indian pharmaceutical company Glenmark, who announced on 27 May 2020 that they had received final approval for generic chlorzoxazone tablets in two doses (375 mg and 750 mg).

Glenmark now has over 160 FDA-approved products, as well as 45 new drug applications pending approval. The drug will be manufactured at their site in North Carolina and is the first drug manufactured at this site to be approved by FDA.

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Reference
1. GaBI Online - Generics and Biosimilars Initiative. FDA approves lung cancer and anticoagulant generics [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jul 3]. Available from: www.gabionline.net/Generics/News/FDA-approves-lung-cancer-and-anticoagulant-generics

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Source: EMA; Glenmark