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Generics of apixaban and chlorzoxazone approved in EU and US

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.

Aurobindo Pharma receives FDA approval for three generics

India-based generics maker Aurobindo Pharma (Aurobindo) has received three approvals from the US Food and Drug Administration (FDA) in recent months, including for its generic versions of guaifenesin, fluoxetine and – via partner company Eugia Pharma – methotrexate.

COVID-19 drugs: Gilead’s remdesivir and Algernon’s alternative

Gilead Sciences has signed licensing agreements with five generics manufacturers based in India and Pakistan to increase production of its experimental COVID-19 drug remdesivir.

FDA approves Proventil and Daraprim generics

The US Food and Drug Administration (FDA) has approved the first generic version of a commonly used inhaler, marketed as Proventil, and the anti-parasitic Daraprim, which has previously been the subject of a price gouging scandal.

FDA approves lung cancer and anticoagulant generics

The US Food and Drug Administration (FDA) has issued a final approval for a generic version of Alimta (pemetrexed) and two new generics of Eliquis (apixaban).

Chinese company makes copy of patented coronavirus treatment remdesivir

China’s BrightGene has successfully produced remdesivir, an experimental treatment for coronavirus, however, patents for the drug are currently held by the American company Gilead.

EMA recommends four new generics

At the Committee for Medicinal Products for Human Use’s (CHMP) January 2020 meeting, the Committee recommended four new generics, and one new biosimilar, for approval.

FDA approves generics for cancer and gout

The US Food and Drug Administration (FDA) has approved two generic versions of Novartis’ anticancer drug Afinitor (everolimus), alongside a generic of Takeda’s gout treatment Uloric (febuxostat).

FDA approves MS and prostate generics

The US Food and Drug Administration (FDA) in December 2019 approved the first generics of Gilenya (fingolimod) for multiple sclerosis (MS) and Rapaflo (silodosin) for benign prostatic hyperplasia.

EMA recommends approval for two new generics

The European Medicines Agency’s (EMA) human medicines committee recommended seven new medicines for approval at its November 2019 meeting, including two generics: clopidogrel/acetylsalicylic acid and deferasirox.