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Betaseron gains FDA approval for pre-filled diluent syringe
California | Wednesday, October 15, 2003, 08:00 Hrs  [IST]

Berlex Inc and Chiron Corporation announced that the U.S. Food and Drug Administration (FDA) has approved a new pre-filled diluent syringe for Betaseron (interferon beta-1b) for SC Injection, making it easier to use for people with multiple sclerosis (MS).

Designed with patient comfort in mind, the pre-filled diluent syringe will continue to provide patients with the proven efficacy of Betaseron. The drug's formulation remains unchanged while the drug delivery mode is enhanced.

This new innovation shortens preparation, helping to simplify injections. This adds another level of convenience for Betaseron users, who already benefit when traveling because the drug does not need to be refrigerated. Betaseron is the first and only FDA-approved interferon therapy that is stable at room temperature for more than 30 days.

"Berlex is committed to developing new therapies and enhancing existing products to provide MS patients with convenient and efficacious therapeutic options. Our latest innovation, the new pre-filled diluent syringe, makes it easier to administer Betaseron than before by reducing the number of steps in the injection process," said Ayad Abdulahad, vice president, medical director, CNS, of Berlex Laboratories. "We also have an aggressive clinical research program, through which we're conducting the world's largest head-to-head MS studies to help guide treatment decisions."

"Building on Betaseron's 10-year history of treating MS, we continue to pursue innovations that help ease the burden for MS patients," said Bruce Scharschmidt, vice president, Clinical Development, Chiron Corporation. "The pre-filled diluent syringe is another step forward in this effort. Similarly, Betaseron's strong clinical results show that we are providing MS patients with important therapeutic benefits."

The new pre-filled diluent syringe for Betaseron is expected to be available nationwide in the next few months.

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