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.
Upsher-Smith launches prenatal vitamin to relieve morning sickness
MAPLE GROVE, Minn. — Drug maker Upsher-Smith Labs has launched a prenatal vitamin designed to help relieve morning sickness, the company said Monday.
Upsher-Smith announced the launch of B-Nexa, which contains B vitamins and ginger to help calm morning sickness, known medically as nausea and vomiting of pregnancy, which affects 83% of pregnant women throughout the day, according to medical experts.
"B-Nexa is a new option in the prenatal nutrition market that has been designed to help calm nausea and vomiting of pregnancy, with vitamin B6 and ginger, while also providing women with essential folic acid," Upsher-Smith senior director of medical affairs Wesley Mark Todd said. "With the launch of B-Nexa, Upsher-Smith is pleased to have another opportunity to demonstrate our commitment to women’s prenatal health."