FDA approves Roxro’s Sprix
MENLO PARK, Calif. The Food and Drug Administration has approved a new nasal spray for treating pain.
Roxro Pharma announced Monday the approval of Sprix (ketorolac tromethamine), used to manage acute moderate to moderately severe pain that requires analgesia at the opioid level. The drug, which is not a narcotic, is designed for short-term pain management, lasting up to five days.
“The FDA approval of Sprix provides an important new tool for physicians treating patients with moderate to moderately severe pain,” Roxro CEO Roberto Rosenkranz said. “This is particularly significant at a time when patients and physicians have become increasingly concerned with use of narcotic pain relievers.”
Teva receives tentative approval for generic Sensipar
JERUSALEM The Food and Drug Administration has granted tentative approval to Teva Pharmaceutical Industries’ generic version of an Amgen drug, Teva said Friday.
The FDA gave the tentative approval to cincacalcet hydrochloride tablets in the 30-mg, 60-mg and 90-mg strengths. The drug is a generic version of Amgen’s Sensipar, which has annual sales of $458 million, according to IMS Health. The drug is used to treat secondary hyperparathyroidism in patients with chronic kidney disease on dialysis.
Tentative approval means that the drug meets most of the conditions for approval, but the FDA cannot grant final approval because the patents covering the drug don’t expire until December 2016, according to FDA records. Teva and Amgen are currently involved in patent litigation concerning the drug in the U.S. District Court for the District of Delaware, though a trial has not been set, Teva said.
RediClinic introduces Teen Health Package
HOUSTON RediClinic is launching in time for summer camp and upcoming school sports a new health package designed specifically for teenagers.
The new Teen Health Package includes a physical exam, an acne consultation and an immunization review for $59.
"We all know that adolescence is a time of great change," stated Susan Cooley King, VP clinical services. "With this in mind, RediClinic created a special health package that addresses the specific health needs of a teen."
Physical exams are always in season. They are required by summer camps and for participation in school sports. During a RedlClinic physical, a clinician evaluates the teen’s medical history. The exam is then performed, checking their physical health including, but not limited to, chest and heart, lymph nodes, blood pressure and abdomen.
Patients of the Teen Health Package also will receive an evaluation of their acne issues and the clinician will make recommendations for the most appropriate treatment ranging from over-the-counter medications to prescriptions.
According to the American Academy of Dermatology, 85% of American teenagers are effected by acne.
Patients also will receive an immunization review whereby the clinician will review the teen’s immunization history, identify which vaccines the patient needs for school admission and administer the vaccines, for an additional charge if necessary.