FDA continued to take important steps to address youth use of e-cigarettes by sending official requests for information to four e-cigarette makers requiring them to submit important documents to better understand the youth appeal.
Category Archives: Food & Drug Recalls
Statement from FDA Commissioner Scott Gottlieb, M.D., on new agency efforts to shine light on situations where drug makers may be pursuing gaming tactics to delay generic competition
FDA statement on certain tactics drug makers may be pursuing to delay generic competition
Mas Food Services Co. Issues Allergy Alert on Undeclared Sulfites in The Peruchef Dry Potato
Mas Food Services Co. of Oakland Park, FL is recalling its 15 ounce packages of The Peruchef brand dry potato because it may contain undeclared sulfites. People who have an allergy or severe sensitivity to sulfites run the risk of serious or life-threatening allergic reaction if they consume these products.
FDA approves the first non-opioid treatment for management of opioid withdrawal symptoms in adults
FDA approved Lucemyra (lofexidine hydrochloride) for the mitigation of withdrawal symptoms to facilitate abrupt discontinuation of opioids in adults.
FDA approves first epoetin alfa biosimilar for the treatment of anemia
FDA approves Retacrit (epoetin alfa-epbx) as a biosimilar to Epogen/Procrit (epoetin alfa) for the treatment of anemia
Apotex Corp. Issues Voluntary Nationwide Recall of Piperacillin and Tazobactam For Injection, USP 3.375 Gram/Vial And 4.5 Gram/Vial Strengths Due to Elevated Levels of Impurities That May Result in Decreased Potency
Apotex Corp. is voluntarily recalling 36 lots of Piperacillin and Tazobactam for Injection, USP 3.375 gram/vial and 4.5 gram/vial strengths, to the consumer/user level. The Piperacillin and Tazobactam for Injection have been found to contain elevated levels of impurities that may result in decreased potency. The affected product is manufactured by Hospira Inc., a Pfizer Company and distributed in the US market by Apotex Corp.
Sugarfina, Inc. Issues Allergen Labeling Alert for Undeclared Eggs in Sugar Cookies Product
Sugarfina, Inc. is recalling its Sugar Cookies product because the label does not declare that this product contains egg. People who have allergies or severe sensitivities to eggs run the risk of serious or life-threatening allergic reaction if they consume this product.
FDA expands approval of Gilenya to treat multiple sclerosis in pediatric patients
FDA approves Gilenya (fingolimod) to treat multiple sclerosis MS in children age 10 and older. This is the first FDA approval of a drug to treat MS in pediatric patients
Statement from FDA Commissioner Scott Gottlieb, M.D., on the Trump Administration’s plan to lower drug prices
Statement from FDA Commissioner Scott Gottlieb, M.D., on the Trump Administration’s plan to lower drug prices
FDA warns more companies to stop misleading kids with e-liquids that resemble kid-friendly foods as part of Youth Tobacco Prevention Plan
FDA warns more companies to stop misleading kids with e-liquids that resemble kid-friendly foods as part of Youth Tobacco Prevention Plan