FDA issues nonapprovable letter over Merck’s Mevacor OTC
WHITEHOUSE STATION, N.J. Merck may yet make a fourth attempt at switching its statin Mevacor over-the-counter, but the Food and Drug Administration officially declined its third attempt, the company reported Friday.
The FDA indicated in its letter that it would require a revised label and additional data from Merck in order to gain marketing approval. “We’re evaluating the conditions outlined in the agency’s response to determine a path forward for Mevacor OTC,” stated Edwin Hemwall, Merck president, global OTC regulatory and scientific affairs.
FDA approves label change for Prilosec OTC
ROCKVILLE, Md. The Food and Drug Administration last week approved Procter & Gamble’s proposed label change for Prilosec OTC.
The design changes include a new Prilosec OTC logo throughout the labeling, a reformatted 2-count professional sample card, a redesigned inner panel of the 2-count consumer sample card, a reformatted package insert and redesigned principal display panel.
The application did not include any changes to the Drug Facts or blister card backing. As part of the approval, P&G must remove “NEW LOOK! SAME RELIEF!” messaging prior to July 18.
Marsh offers free vitamin program for expectant mothers
INDIANAPOLIS Marsh Supermarkets on Thursday implemented a new program designed to help expectant mothers manage health care costs with its Prenatal Select Program, a program that provides free prenatal vitamins using selected products made by the Ethex Corporation.
“We at Marsh understand that while pregnancy is a time of joy, it can also bring with it many concerns,” stated Chris Duffy, Marsh vice president of pharmacy. “Marsh is happy to help alleviate one financial concern with the introduction of our free prenatal vitamin program.”
The news comes in the same month that the Centers for Disease Control and Prevention reported that younger women between the ages of 18 and 24 are the least aware of the benefits in supplementing with folic acid during pregnancy.
In analyzing the results of five national surveys conducted annually by the Gallup Organization between 2003 and 2007, 61 percent of women in this age group were aware of the benefits of folic acid, but only 6 percent knew when folic acid should be taken. In addition, only 30 percent of women in this age group, which accounts for approximately one-third of all births, supplemented with folic acid.
The program is available to anyone with a valid prescription for prenatal vitamins. Once the prescription is presented, the shopper can receive 30 day despensings of selected prenatal vitamins absolutely free with no strings attached for up to one year. The Prenatal Select Program is available at all 41 Marsh pharmacy locations in Indiana. Marsh Pharmacists are available to explain the program and answer any questions.