FDA approves new injector pen for Merck KGaA fertility drug
DARMSTADT, Germany — The Food and Drug Administration has approved a pre-filled injector pen made by EMD Serono for infertile women, the company said Friday.
The drug maker — the U.S. subsidiary of Germany’s Merck Serono, so-called to distinguish it from U.S.-based Merck & Co. — announced the approval of Gonal-f RFF Redi-ject (follitropin alfa), a disposable pre-filled injector pen intended for injection under the skin of a liquid formulation of Gonal-f RFF. The pens will be available in the United States in December.
"With a complete portfolio of gonadotropins, Merck Serono is continuously innovating to improve its administration devices in order to meet the needs of patients and healthcare professionals," Merck Serono global head of research and development Annalisa Jenkins said. "We have a strong legacy in fertility, and the approval of the Gonal-F RFF Redi-ject in the [United States] further demonstrates our commitment to building our leadership position in this important therapeutic area as we look to the future."
Merck Serono, itself part of Merck KGaA, was originally the parent company of Merck & Co., but the two were split during World War I as part of a broader seizure of German assets in the United States.
FDA approves UCB’s Cimzia for ankylosing spondylitis
ATLANTA — The Food and Drug Administration has approved a drug made by UCB for treating a form of arthritis.
The drug maker said Friday that the FDA had approved Cimzia (certolizumab pegol) for adults with active ankylosing spondylitis, though it declined to approve the drug for axial spondyloarthritis, or axSpA. UCB said it was working with the agency to determine how to get the drug approved for axSpA.
"[Ankylosing spondylitis] is a lifelong disease that can cause pain and stiffness and, at times, can be very debilitating for people living with it," UCB EVP and chief medical officer Irish Loew-Friedrich said. "Cimzia provides an important new treatment option for people living with active AS an for rheumatologists."
Giant-Carlisle sponsors drug take-back drive
CARLISLE, Pa. — Giant Food Stores and Martin’s Food Markets — collectively known as Giant-Carlisle — will sponsor drug take-back events at more than three dozen stores next weekend.
The Ahold USA-owned supermarket banner said customers could bring expired and unwanted drugs to 42 stores on Oct. 26; 40 of the stores are in Pennsylvania, and two are in Virginia.
All medications will be disposed of in an environmentally friendly manner at no cost to the customer, though the chain recommended that customers remove or cross out such personal information as names and addresses. During the last program, in April, participating store collected 4,392 pounds of medications.