Posted by Michael Wonder on 30 Mar 2016
Additional dosage strengths of Otrexup (methotrexate) injection approved by FDA
29 March 2016 - Antares Pharma today announced the approval by the U.S. Food and Drug Administration (FDA) of three new dosage strengths of Otrexup (methotrexate) injection. The new dosage strengths of 12.5 mg/0.4 mL, 17.5 mg/0.4 mL and 22.5 mg/0.4 mL will complement the already approved and marketed strengths of 7.5 mg/0.4 mL, 10 mg/0.4 mL, 15 mg/0.4 mL, 20 mg/0.4 mL and 25 mg/0.4 mL. New, interim dose strength options will enable physicians to select more specific, optimal doses to help achieve patient treatment goals.
“Otrexup has always been available in the most commonly prescribed strengths of methotrexate, but our new interim dose options may provide physicians even more opportunity to give their patients precisely what is needed to achieve disease control,” said Robert Apple, President and Chief Executive Officer of Antares Pharma. “Each and every patient treatment regimen is different, so providing a step approach to therapy may extend and optimize the use of Otrexup for patients. New interim strengths are also covered by Otrexup TotalCare so all eight dosing options are eligible for up to $125 of patient co-pay assistance.
For more details, go to: http://www.antarespharma.com/files/2914/5919/1898/OTREXUP_FDA_approval_of_sNDA.pdf
