Shionogi launches Cuvposa, partners with Diplomat Specialty Pharmacy
FLORHAM PARK, N.J. — A treatment made by Shionogi for chronic, severe drooling in children and teenagers with neurological conditions has become available, the drug maker said Thursday.
Shionogi announced the availability of Cuvposa (glycopyrrolate) oral solution for children ages 3 to 16 years with such conditions as cerebral palsy. The company also has a partnership with Diplomat Specialty Pharmacy to grant caregivers convenient access to the drug through a patient’s physician, allowing Diplomat to fill the prescription and ship the drug once the physician places an order and it’s verified.
“Shionogi is proud to expand its mission of helping to bring high-quality care to pediatric patients by introducing Cuvposa to the U.S. market,” Shionogi chief medical officer Donald Manning said. “Unlike tablet formulations, liquid Cuvposa does not require compounding by a pharmacist before it is administered by caregivers, providing families with a new approach to treating chronic, severe drooling in children and adolescents with neurologic conditions.”
Horizant OKed as restless legs syndrome treatment
SILVER SPRING, Md. — The Food and Drug Administration has approved a drug made by GlaxoSmithKline and Xenoport for treating restless legs syndrome, the agency said Thursday.
The FDA approved Horizant (gabapentin enacarbil) as a once-daily treatment for moderate-to-severe RLS.
“People with restless legs syndrome can experience considerable distress from their symptoms,” FDA Division of Neurology Products director Russell Katz said. “Horizant provides significant help in treating these symptoms.”
AstraZeneca’s vandetanib receives approval from FDA
SILVER SPRING, Md. — The Food and Drug Administration has approved a drug made by AstraZeneca for treating a rare form of thyroid cancer, the agency said.
The FDA announced the approval of the daily pill vandetanib for late-stage medullary thyroid cancer in patients whose disease is growing and causing symptoms but who are ineligible for surgery.
Medullary thyroid cancer involves specific cells found in the thyroid gland and can occur spontaneously or be part of a genetic disease. There currently are no FDA-approved treatments for this cancer.