FDA approves Safyral
WAYNE, N.J. — The Food and Drug Administration has approved a new oral contraceptive developed by Bayer.
Safyral is a combination of Yasmin, also developed by Bayer, with 451 mcg levomefolate calcium, which is a B vitamin known as a folate. It is the second oral contraceptive from Bayer that features folate.
"With the FDA approval of Safyral, Bayer now offers two oral contraceptives that contain folate," said Leslie North, VP women’s healthcare marketing at Bayer HealthCare Pharmaceuticals. "Safyral and Beyaz are part of Bayer’s growing women’s health franchise, and these new products reinforce our commitment to providing women various contraceptive options."
FDA declines to approve Brilinta
WILMINGTON, Del. — The Food and Drug Administration has turned down AstraZeneca’s regulatory approval application for a drug to treat heart disease, the drug maker said.
The agency sent AstraZeneca a complete response letter requesting additional analyses of data from a clinical study of Brilinta (ticagrelor), but did not request additional studies. The drug is designed to treat acute coronary syndromes.
A complete response letter means that the FDA has completed its review of a drug application, but issues remain that preclude final approval.
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Eileen Myers joins The Little Clinic
BRENTWOOD, Tenn. — The Little Clinic has appointed Eileen Myers as director of prevention and health management. She will be responsible for leading the health-and-wellness initiatives and for overseeing the rollout of an expanded scope of services for the clinic operator.
Myers most recently worked as a private practice dietitian, counseling patients with weight and eating disorder issues. She also has been a consultant, providing motivational interviewing and behavior change strategy expertise for business and industry organizations. She has worked closely with The Little Clinic for three years as a consultant on scope of services and SmartPath Prevention programs.
"We are pleased to officially welcome Eileen Myers to our team," stated Ford Brewer, chief medical officer for The Little Clinic. "Her work with The Little Clinic over the past three years has been an asset as we continue to provide quality, affordable health care to our customers."
The Little Clinic currently operates healthcare clinics inside select Kroger stores in Kentucky, Tennessee and Ohio; King Sooper in Colorado; Fry’s Food Stores in Arizona; and Publix supermarkets in Georgia and Florida.
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