FDA approves new administration method for Takeda cancer drug
CAMBRIDGE, Mass. — The Food and Drug Administration has approved a new means of administering a cancer drug made by Takeda, the drug maker said.
The FDA approved injection under the skin of Velcade (bortezomib) for multiple myeloma and mantle-cell lymphoma, also known as subcutaneous injection.
Takeda said the approval was based on results of a phase-3 trial conducted on 222 patients who had not received the drug before that showed subcutaneous injection worked as well as intravenous injection.
FDA OKs Genzyme plant in Massachusetts
CAMBRIDGE, Mass. — The Food and Drug Administration has approved a new manufacturing plant that will be operated by drug maker Genzyme.
Genzyme said the plant, located in Framingham, Mass., will help the company continue the production of Fabrazyme (agalsidase beta), a Fabry disease treatment, so that patients can be return to the full dosing levels (1 mg/kg).
“We are very pleased with the FDA approval of our Framingham plant as we continue our manufacturing recovery and path forward to serve the Fabry patient community,” Genzyme president and CEO David Meeker said. “With this approval, we continue upon our 2012 plan to restore unconstrained supply for all patients globally throughout the course of the year.”
Oxecta now commercially available
PALATINE, Ill. — A pain medication that utilizes Acura Pharmaceuticals’ Aversion technology now is commercially available.
Acura said it was informed by Pfizer that Oxecta has hit the market in 5-mg and 7.5-mg strengths, which will be sold in 100-count bottles. Oxecta is indicated for the management of acute and chronic moderate to severe pain where the use of an opioid analgesic is appropriate.
"The commercial availability of Oxecta is an important milestone and we are pleased Pfizer continues to advance the commercialization plan for Oxecta," Acura CEO Bob Jones said.
Acura has exclusively licensed the Aversion technology to Pfizer in the United States, Canada and Mexico for use in four opioid-based pain products.