FDA approves marketing of Rebetol separately for use with Intron-A

המיגע באדיבות מדיקונטקסט
Last Updated: 2001-07-26 11:42:11 EDT (Reuters Health)

NEW YORK (Reuters Health) – Schering-Plough Corp. announced on Thursday that the US Food and Drug Administration (FDA) has approved the sale of the company's hepatitis C drug Rebetol (ribavirin) as a stand-alone product.

Previously, Schering-Plough was only allowed to sell Rebetol with the injectable antiviral Intron-A (interferon alpha-2b, recombinant) in a single package, marketed as Rebetron.

Although Rebetol is still only officially cleared for use with Intron-A, with its approval as a product separate from Intron-A some industry experts saw the potential for physicians to prescribe the therapy off-label with Peg-Intron (peginterferon alpha-2b), an approved long-acting version of Intron-A that incorporates pegylation technology.

Schering-Plough filed the combination of Rebetol and Peg-Intron for approval with the FDA in January. After being fast-tracked by the agency, the company now expects a decision by early August.

However, Schering-Plough said that Rebetol capsules would not be available as a single product until the fall, eliminating the possibility of such off-label use.

According to a Schering-Plough spokesman, the company expects that Rebetol would be used "only if [Rebetron] patients needed a dose modification" supplementing the combination therapy with additional ribavirin.

Prudential Securities analyst Tim Anderson called Schering-Plough's failure to launch Rebetol before the fall "curious," adding that he would have expected the company to have made arrangements to get the product on the market as soon as possible.

The Schering-Plough spokesman told Reuters Health that "there is a certain amount of time it takes … to prepare a product and prepare launch activities."

He added that the company wanted to ensure "an adequate supply of the product to meet the needs of the market."

During late-morning trading on the New York Stock Exchange, shares of Kenilworth, New Jersey-based Schering-Plough rose 1.28 to 38.48.

-New York Newsroom 212 273 1700

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