FDA Approves Individual Sales of Schering-Plough’s Hepatitis C Drug Ribavirin
The FDA yesterday gave Schering-Plough permission to sell ribavirin -- one of the drugs in its two-drug hepatitis C treatment -- separately under the name Rebetol, the AP/New York Times reports. Schering-Plough previously packaged ribavirin and interferon-A together under the brand name Rebetron. Until now, Rebetron has been the only FDA-approved method for patients to obtain ribavirin (AP/New York Times, 7/27). According to an FDA release, the separation of ribavirin and interferon-A will allow physicians greater "flexibility" in adjusting drug dosages and combinations for patients (FDA release, 7/26). Although a Schering-Plough spokesperson said that Rebetol is only approved for use with the company's brand of interferon-A, called Intron A, the AP/Dallas Morning News reports that because physicians can prescribe drugs for off-label use, they may prescribe Rebetol with other brands of interferon (AP/Dallas Morning News, 7/27). Reuters/Los Angeles Times reports that physicians have "held off" prescribing Rebetron because they want to write separate prescriptions for Rebetol and Schering-Plough's "new and longer-acting" form of interferon called Peg-Intron, which was approved last January as a stand-alone product (Los Angeles Times, 7/27). Schering-Plough has applied for FDA approval of Rebetol and Peg-Intron as a combination therapy and will hear from the agency next month on that decision (Krauskopf, Bergen Record, 7/27). Sales of Rebetol are scheduled to begin this fall, but Schering-Plough declined to give a price estimate for the drug (AP/New York Times, 7/27).This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.