Content on PharmTech.com this week ranged from fundamentals on the use of digital pathology in drug development, discussions on the use of AI in pharma, and regulatory actions impacting the industry.
News|Articles|January 31, 2014
Teva Announces FDA Approval of a New Dose of Copaxone
Author(s)Melanie Sena
Teva reports FDA approval for three-times-a-week Copaxone 40 mg/mL.
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Teva Pharmaceutical Industries
reported that FDA has approved the company’s supplemental new drug application for three-times-a-week Copaxone 40mg/mL, a new dose of Copaxone. This new formulation will allow for a less frequent dosing regimen administered subcutaneously for patients with relapsing forms of multiple sclerosis (MS). In addition to the newly approved dose, daily Copaxone 20 mg/mL will continue to be available.
The FDA approval is based on data from the Phase III Glatiramer Acetate Low-Frequency Administration study of more than 1400 patients, which showed that a 40 mg/mL dose of Copaxone administered subcutaneously three-times-a-week significantly reduced relapse rates at 12 months and demonstrated a favorable safety and tolerability profile in patients with relapsing-remitting MS.
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Teva Pharmaceutical Industries
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