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Related Topics >> FDA | Regulators | Novartis | Prexige | drug safety | Reclast

Novartis gains Aclasta, loses Prexige

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From the good news, bad news file: Novartis got the EU's approval to sell its new osteoporosis drug Aclasta, known in the U.S. as Reclast. Reclast got the FDA's nod six weeks ago, and analysts are saying the drug is likely to generate $1.2 billion in sales by 2011--which unfortunately happens to be the year when its active ingredient goes off patent.

Practically simultaneously to the E.U.'s blessing on Aclasta, Canadian regulators pulled the pain pill Prexige because of the same liver-damage fears that brought it down in Australia in August. Some experts called Health Canada's ban a "knee-jerk" reaction; others questioned the fact that Prexige was approved at all, considering that it's a Cox-2 inhibitor, a class of drugs known to cause serious side effects.

You'll recall that Novartis and its stock analysts had big hopes for Prexige, once predicting yearly sales of $1 billion or more. So far this year, it's only generated $52 million.

- here's the press release on Aclasta
- see the MarketWatch article about Aclasta
- read this report on Prexige

Related Articles:
FDA says Aclasta "approvable" for Paget's. Report
Novartis' Reclast gets FDA blessing. Report
Australia bans Novartis' Prexige. Report
Vasella doubtful of Prexige approval. Report

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