Regulatory and Washington

WHITEHOUSE STATION, N.J. — The Food and Drug Administration has accepted a regulatory approval application for a drug to treat Type 2 diabetes made by Merck, the drug maker said Tuesday.

Merck announced the acceptance of its application for extended-release Janumet, which combines in a single pill the active ingredient sitagliptin with extended-release metformin, a drug commonly prescribed for Type 2 diabetes.

WAYNE, N.J. — Bayer HealthCare Pharmaceuticals sought to reassure healthcare professionals and their patients that a recall of alcohol prep pads distributed with its multiple sclerosis drug did not affect the drug itself.

The drug maker’s MS treatment Betaseron (interferon beta-1b) is distributed with prep pads made by Triad Group, which recently staged a recall of prep products due to potential contamination with Bacillus cereus bacteria, which would lead to life-threatening infections.

MORRISTOWN, N.J. — The Food and Drug Administration has approved a generic drug made by Watson Pharmaceuticals for cancer-related pain, Watson said Monday.

Watson announced the approval of fentanyl buccal tablets in the 0.1-mg, 0.2-mg, 0.6-mg and 0.8-mg strengths.

HUNTINGTON, N.Y. — Rep. Steve Israel, D-N.Y., plans to introduce new legislation soon to make medicine cups and other dosage devices commonly used to give medicine to children safer, the Congress leader recently announced. However, the need for such a bill may be moot as the over-the-counter industry already is actively initiating guidelines to standardize dosing directions and units of measuring that dose.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug for treating pain in cancer patients, the agency said Friday.

The FDA announced the approval of ProStrakan’s Abstral (fentanyl) transmucosal tablets for the management of pain that appears suddenly for short periods and is not alleviated by a patient’s normal pain-management plan, also known as breakthrough pain. The tablets are designed for administration on the soft surfaces of the mouth, including inside the cheek, gums and tongue, as well as the nasal passages or the throat.

WASHINGTON — The Council for Responsible Nutrition on Friday announced a partnership with New Hope Natural Media’s NPIcenter, in which CRN will provide a monthly blog commentary posted on the supplement industry website, NPIcenter.com, as well as on the newly launched NewHope360.com.

CHADDS FORD, Pa. — The Food and Drug Administration declined to approve Endo Pharmaceuticals’ regulatory application for a painkiller designed to thwart drug abusers, Endo said Friday.

SILVER SPRING, Md. — Nearly 500 retailers in Mississippi had to submit to Food and Drug Administration inspections concerning alleged tobacco sales to minors, the FDA said Friday.

The FDA said it visited 493 retailers and issued 25 warning letters over the last three months using state inspectors the agency had commissioned. Mississippi was the first state to participate in the FDA’s State Enforcement Program, which started in the summer and is designed to enforce provisions of the Family Smoking Prevention and Tobacco Control Act of 2009 and implement regulations.