A summertime battle is expected between Neurocrine and Teva once both companies get their tardive dyskinesia drugs on the US market, but Neurocrine's April 11 approval for Ingrezza without an FDA warning label is already giving the biotech an edge.
The US approval for Neurocrine Biosciences Inc.'s Ingrezza (valbenazine), without a black box warning, for the treatment of adults with tardive dyskinesia is the best possible scenario for the San Diego biotech – giving the drug a solid head start against competitor Teva Pharmaceutical Industries Ltd.'s Austedo (deutetrabenazine).
Ingrezza became the first product to be approved for adults with tardive dyskinesia (TD), an involuntary neurological movement disorder caused...
<p>Executive Summary</p> <p>A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.</p>
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<p>Executive Summary</p> <p>A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.</p>
