Aries gets FDA green light for Aemcolo
Aries Pharmaceuticals has received the Food and Drug Administration’s clearance for Aemcolo (rifamycin) 194 mg delayed-release tablets, a new minimally absorbed antibiotic that is delivered to the colon for the treatment of adult patients with travelers’ diarrhea caused by noninvasive strains of E. coli.
In October 2017, the FDA granted Qualified Infectious Disease Product and Fast Track designations for Aemcolo.
The product will be available in pharmacies in the first quarter of 2019, the company said
“Travelers’ diarrhea can be highly disruptive and cause significant discomfort for patients, and, in some cases, it can progress to more serious conditions if not treated effectively. The recent approval of Aemcolo is an important step for Aries as we continue to grow our portfolio to address important unmet needs in the GI community,” Aries Pharmaceuticals CEO Tom Joyce said.
Indivior gets FDA nod for Perseris
The Food and Drug Administration has given the OK for Indivior’s Perseris (risperidone) for extended-release injectable suspension for the treatment of schizophrenia in adults.
Perseris contains risperidone, a well-established medicine for schizophrenia, and uses an extended-release delivery system to form a subcutaneous depot that provides sustained levels of risperidone over one month.
“The availability of Perseris provides physicians with a new treatment option to help address some of the challenges in treating schizophrenia,” Indivior’s CEO Shaun Thaxter said. “We understand the complex patient journey of people living with schizophrenia and recognize the important role that long-acting injectables can play. Perseris is a demonstration of our ongoing commitment to developing innovative treatments for people living with this debilitating condition.”
Nexus gets FDA nod for generic Trisenox
Nexus Pharmaceuticals has received the Food and Drug Administration’s blessing for arsenic trioxide injection, a generic version of Teva’s Trisenox.
The generic Trisenox, which is available in 10 mg per 10 mL vial for injection, is indicated for relapsed or refractory acute promyelocytic leukemia.
“The approval of generic arsenic trioxide injection continues to show Nexus’s commitment in providing access to affordable critical-need generic injectables,” Nexus chief commercial officer Omair Ahmed said. “Collectively, as drug manufacturers and healthcare providers, we have a commitment to patients to ensure they are receiving affordable drugs they need, when they need them, which is why we make it our highest priority to be a reliable partner in supplying critical-need drugs.”