Alzheimer’s disease draft guidance

February is American Heart Month, and the U.S. Food and Drug Administration has a tool to help you achieve a heart-healthy lifestyle. It’s called the Nutrition Facts Label, and it can be found on all packaged foods and beverages.

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Green Hope LLC, which does business as Rosewood Products, and owner, Phi G. Ye, of Ann Arbor, Mich., have agreed to a consent decree of permanent injunction for violations of FDA food safety regulations. The consent decree was signed by Judge David M. Lawson of the U.S. District Court for the Eastern District of Michigan, Southern Division, on January 28, 2013.

The U.S. Food and Drug Administration today approved Ravicti (glycerol phenylbutyrate) for the chronic management of some urea cycle disorders (UCDs) in patients ages 2 years and older.

The U.S. Food and Drug Administration announced today that a federal judge has approved a consent decree of permanent injunction against Ben Venue Laboratories, Inc., and three of its corporate officers for failing to comply with current good manufacturing practice requirements as required by federal law.

The U.S. Food and Drug Administration today approved Kynamro (mipomersen sodium) injection as an addition to lipid-lowering medications and diet to treat patients with a rare type of high cholesterol called homozygous familial hypercholesterolemia (HoFH). The addition of Kynamro helps to reduce low-density lipoprotein-cholesterol (LDL-C), apolipoprotein B, total cholesterol, and non-high density lipoprotein-cholesterol (non HDL-C).

The U.S. Food and Drug Administration announced today that Jonlly Fruits, Inc. (Jonlly), and its President, Bartolo Pérez Román (Defendants), have signed a consent decree of permanent injunction prohibiting distribution of their fruit and juice products sold under Jonlly’s own label, as well as “Natural Tropic,” “Selectos,” and several other private-label brands.

The U.S. Food and Drug Administration today approved a new use of Gleevec (imatinib) to treat children newly diagnosed with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia (ALL).

The U.S. Food and Drug Administration today approved three new related products for use with diet and exercise to improve blood sugar control in adults with type 2 diabetes: Nesina (alogliptin) tablets, Kazano (alogliptin and metformin hydrochloride) tablets, and Oseni (alogliptin and pioglitazone) tablets.