Regulatory and Washington

Supplier News — Cirrus Healthcare Products recently introduced its ClearEars product, earplugs that contain a polymer that draws water from the ears. ClearEars also is appropriate to alleviate symptoms of glue ear, a condition in which thick, sticky fluid collects behind the eardrum.


PITTSBURGH — The Food and Drug Administration has given tentative approval to a generic drug for HIV/AIDS made by Mylan subsidiary Matrix Labs for distribution in developing countries under the President’s Emergency Plan for AIDS Relief, Mylan said Tuesday.

The tentative approval under PEPFAR covers Matrix’s abacavir sulfate tablets in the 60-mg strength. The drug is a generic version of ViiV Healthcare’s Ziagen, and is used to treat the disease in children.

WASHINGTON — The Consumer Healthcare Products Association recently named GlaxoSmithKline veteran Janet Carter-Smith chair of the CHPA Retailer Liaison Steering Committee, effective Jan. 1.

Carter-Smith will be the third chair of this committee, succeeding David Howenstine, VP customer and industry development at Pfizer Consumer Healthcare, whose term ends at the end of the year.

ATLANTA — The Centers for Disease Control and Prevention has set aside the week of Dec. 5 to observe this season's National Influenza Vaccination Week. The week-long emphasis on flu vaccination was established to highlight the importance of continuing influenza vaccination, as well as foster greater use of flu vaccine after the holiday season into January and beyond.

SCHAUMBURG, Ill. — The Food and Drug Administration has approved a generic chemotherapy drug made by Sagent Pharmaceuticals, Sagent said Thursday.

The FDA approved topotecan hydrochloride for injection, a version of GlaxoSmithKline’s Hycamtin. The U.S. market for injectable topotecan was around $158 million in 2010, according to IMS Health.

CAPE GIRARDEAU, Mo. (Dec. 1) Gov. Jay Nixon, D-Mo., on Tuesday campaigned for a sweeping expansion of efforts to battle methamphetamine, including legislation that would make Missouri the third state in the nation to require a prescription for the cough-cold ingredient pseudoephedrine.

It’s not a new issue for the Show Me State — several local municipalities that fall between St. Louis and the Missouri capital of Jefferson City last year passed local ordinances that required prescriptions for PSE products.

WASHINGTON — The Institute of Medicine on Tuesday issued a report on the dietary reference intake levels for vitamin D and calcium at the behest of both the U.S. and Canadian governments. IOM recommended a slight increase in vitamin D intake, but also suggested that the need for either vitamin D or calcium may be overstated.

HAYWARD, Calif. — A generic version of a drug indicated to treat attention deficit hyperactivity disorder has hit a roadblock.