Bionovo receives CMC approval for Menerba
EMERYVILLE, Calif. The Food and Drug Administration has approved a manufacturing plan for a drug to treat hot flashes in menopausal women.
Bionovo said Thursday that the FDA had accepted its chemistry, manufacturing and controls plan for the drug Menerba. The decisions and agreements are considered binding on the company and the FDA.
“This CMC approval represents a revolutionary set of ‘firsts,’” Bionovo chairman and CEO Isaac Cohen said. “This is the first time that the FDA’s botanical drug development CMC guidance has been applied to an oral drug in a major indication.”
Abbott recalls specific Similac powder infant formulas
ABBOTT PARK, Ill. Abbott on Wednesday initiated a proactive, voluntary recall of certain Similac powder infant formulas in the United States, Puerto Rico, Guam and some countries in the Caribbean following an internal quality review, which detected the remote possibility of the presence of a small common beetle in the product, produced in one production area in a single manufacturing facility.
"Abbott understands that parents expect to feed their children only the highest-quality product,” stated Holger Liepmann, EVP Abbott Nutrition. “We are taking this action so that parents know that the infant formula products they provide unquestionably meet the highest-quality standards for which they are known. We regret any inconvenience this situation poses to parents and consumers."
The Food and Drug Administration has determined that while the formula containing these beetles poses no immediate health risk, there is a possibility that infants who consume formula containing the beetles or their larvae, could experience symptoms of gastrointestinal discomfort and refusal to eat as a result of small insect parts irritating the GI tract. If these symptoms persist for more than a few days, a physician should be consulted.
To immediately find out if the product in your possession is included in this recall, parents and caregivers should visit Similac.com/recall, and type in their lot number to determine if their product is affected, or call (800) 986-8850.
No Abbott liquid infant formulas are impacted. Products not involved in the recall include all Abbott Nutrition liquid ready-to-feed and concentrated infant formulas, and all powder and liquid specialty formulas, such as Similac Expert Care Alimentum, Elecare, Similac Expert Care Neosure, Similac Human Milk Fortifier, and metabolic formulas for inherited disorders.
Dietitian joins local ShopRite stores
KEASBEY, N.J. ShopRite stores in Canton and West Hartford, Conn., are looking to help shoppers make healthier food choices by introducing a registered dietitian, according to a local news report.
Registered dietitian Angela Corcoran will be available, effective immediately, to help shoppers. She will conduct free grocery shopping tours, healthy cooking classes, offer recipe and pantry makeovers, and coordinate other health-and-wellness initiatives and nutritional programs in-store, the report stated.
“Having a dietitian in store is just another way that we go above and beyond to provide value and service to our customers,” store president Chuck Joseph was quoted as saying.