Regulatory and Washington

NASHVILLE, Tenn. — Tennessee makes the third state this year, joining Kentucky and Nevada, that is considering state legislation to mandate the sale of pseudoephedrine as prescription-only. That could prove a big concern for the legitimate market for PSE products on account of the potential snowball effect such legislation could have on neighboring states. According to a government review staff in Kentucky, at least 97.8% of all PSE sales are bought for legitimate use.

Generic drug usage already has been on the rise year after year, with no sign of slowing down. As Jody Fisher, VP marketing for healthcare analytics at market research firm SDI, has told Drug Store News, generics accounted for more than 70% of products dispensed at retail pharmacies and are set to increase further this year.


HAYWARD, Calif. — Impax Labs received regulatory approval from the Food and Drug Administration for its generic version of a bacterial infection treatment.

The drug maker on Friday said it received final approval of its abbreviated new drug application for doxycyline monohydrate capsules in the 150-mg strength. The drug, which is a tetracycline antibiotic used to treat bacterial infections, is a generic version of Adoxa. Adoxa is manufactured by PharmDerm, a Nycomed subsidiary.

Impax said its generic division, Global Pharmaceuticals, will launch the product.

SILVER SPRING, Md. — An asthma drug widely available as a generic should not be used for preventing or treating preterm labor in pregnant women, the Food and Drug Administration warned.

All the hype around H1N1 
that was so prevalent in 2009 is gone, leaving only the tough comparisons a year later. That makes the first half of the 
2010-2011 cough-cold season an H1N1 hangover with overall sales of $4.6 billion, representing a slight decline of 1.8%, for the 52 weeks ended Dec. 26, 2010, according to SymphonyIRI Group. What was missing in 2010 was the 2009 summer of sickness that reached a crescendo in September.

“Smah-ten up, Ee-dah.” Loosely translated from deep “Mainer-ese,” that means, “smarten up, Eder.”


It’s a voice from my childhood, an old coach and counselor from summer camp, Tobias Woodworth. I called him Toby. He called me “Ee-dah.”


Stuck with me and all my other quasi-incorrigible New York City friends, Toby found himself saying, “smah-ten up!” an awful lot. It could mean anything from “you’ve got two strikes — protect the plate” to “put down that rock.”


WASHINGTON — February is American Heart Month, and a professional group representing the country’s pharmacists is using that as an opportunity to encourage the public to learn how to prevent heart disease from the most easily accessible members of the healthcare system.

SILVER SPRING, Md. — The Food and Drug Administration has seized supplies of a drug used to treat ear infections, under a program the agency started to remove unapproved drugs from the market.

The FDA announced the seizure of about $16.5 million worth of Auralgan otic solution made by Brooks, Ky.-based Integrated Commercialization Solutions. Chapel Hill, N.C.-based Deston Therapeutics manufactures the drug, while ICS warehouses it.