Regulatory and Washington

MONROVIA, Calif. — Biotab Nutraceuticals on Tuesday initiated a voluntary recall of two lots of Extenze nutritional supplement tablets.

Some packages bearing lot numbers 0709241 and 0509075 are counterfeit products containing undeclared drug ingredients that can pose a serious risk to health, the company stated.

AMITYVILLE, N.Y. — Generic drug maker Hi-Tech Pharmacal has received Food and Drug Administration approval for its version of a drug used to treat neurological disorders, the company said Tuesday.

Hi-Tech announced the approval of gabapentin oral solution in the 250 mg/5 mL strength, a generic version of Pfizer’s Neurontin oral solution.

The drug is used to treat postherpetic neuralgia and epilepsy. Neurontin had sales of $15 million in 2010, according to IMS Health.

ALLEGAN, Mich. — Generic drug maker Perrigo has filed for approval of a drug to treat psoriasis with the Food and Drug Administration.

Perrigo announced Tuesday that it had filed an application with the FDA for calcipotriene and betamethasone dipropionate in the 0.005%/0.064% strength. The drug is a generic version of Leo Pharma’s Taclonex and is used to treat psoriasis vulgaris in adults.

ORLANDO, Fla. — The Generic Pharmaceutical Association has elected its 2011 executive committee and board of directors, the generic drug industry trade group announced. As part of a reorganization last year, the board has been reduced to 12 members.

The GPhA said Watson Pharmaceuticals president and CEO Paul Bisaro had been reelected as chairman for a second, one-year term. Also elected were Mylan Pharmaceuticals president Tony Mauro, as vice chairman; and Momenta Pharmaceuticals president Craig Wheeler, as secretary treasurer.

LITTLE ROCK, Ark. — Arkansas on Friday became the fourth state this year to entertain making the popular decongestant pseudoephedrine available only by prescription.

WASHINGTON — The Medicare Fraud Strike Force on Thursday charged 111 defendants in nine cities — including doctors, nurses and healthcare company owners and executives — for their alleged participation in Medicare fraud schemes involving more than $225 million in false billing. The operation marks the largest federal healthcare-fraud takedown.

SILVER SPRING, Md. — The Food and Drug Administration has approved a treatment for a rare bleeding disorder.

The FDA announced the approval of Corifact, used to prevent bleeding in people with the genetic disorder congenital Factor XIII deficiency, which affects 1-in-3 million to 5 million people in the United States.

The drug is manufactured by Marburg, Germany-based CSL Behring.

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.