Trade Resources Industry Views The USFDA Has Accepted Teva Pharmaceutical Industries' sNDA

The USFDA Has Accepted Teva Pharmaceutical Industries' sNDA

The USFDA has accepted Teva Pharmaceutical Industries' supplemental new drug application (sNDA) for reviewing Copaxone (glatiramer acetate injection) 40mg/1mL.

Indicated for patients with relapsing-remitting multiple sclerosis (RRMS), the higher dose offers subcutaneous administration of thrice a week dosing regimen.

Copaxone 20mg/1mL dose is currently approved for subcutaneous administration once a day, while the drug is indicated even for patients experiencing a first clinical episode and have MRI features in line with multiple sclerosis.

Teva Pharmaceuticals Industries global R&D and chief scientific officer president Michael Hayden said that if COPAXONE 40mg/ 1mL given three times weekly is approved, patients and their physicians will have flexibility in choosing a dosing regimen that works best for them.

"With a strong heritage in MS research innovation, Teva continues to demonstrate its commitment to patients by developing new treatment options to benefit the RRMS community," Hayden added.

Redness, pain, swelling, itching, or a lump at injection site, flushing, rash, shortness of breath and chest pain are the most commonly associated side effects with the medication.

The drug had already been approved in over 50 countries including the US, Russia, Canada, Mexico, Australia, Israel, and all European countries.


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FDA Accepts Supplemental New Drug Application for Teva's Copaxone 40mg/1ml