Regulatory and Washington

SILVER SPRING, Md. — The Food and Drug Administration is warning that long-term use of a class of drugs for gastroesophageal reflux disease may decrease levels of magnesium in the body and increase the risk of such side effects as seizures and heart rhythm problems, according to published reports.

The reports quoted the FDA as saying that in a quarter of cases of proton-pump inhibitors depleting magnesium from the body, use of magnesium supplements did not bring levels back to normal, and use of the drugs had to be stopped.

JERUSALEM — Teva on Tuesday said that a trial date has been set for its ongoing patent infringement litigation against several drug makers.

Teva said the U.S. District Court for the Southern District of New York will commence proceedings Sept. 7. Teva's litigation is against Momenta Pharmaceuticals/Sandoz and Mylan Pharmaceuticals/Mylan/Natco Pharma regarding their purported generic versions of Copaxone (glatiramer acetate injection).

SILVER SPRING, Md. — The Food and Drug Administration has approved a treatment for chronic obstructive pulmonary disease made by Forest Labs, the agency said Tuesday.

HUDDINGE, Sweden — Meda has launched a new cold sore treatment made by commercialization partner Medivir, Medivir said Tuesday.

The Swedish drug maker launched Xerese (acyclovir and hydrocortisone), a topical combination product designed to treat recurrent herpes simplex labialis.

Medivir said the U.S. market for cold sore products is $230 million, and it expected the drug to be successful, given Meda’s presence in the U.S. market.

WASHINGTON — The National Retail Federation last week responded to the Federal Reserve's proposal to cap debit card swipe fees at 12 cents per transaction.

PHILADELPHIA — The Food and Drug Administration has approved a new use for a Shire drug to treat attention deficit hyperactivity disorder, Shire said Monday.

The FDA approved Intuniv (guanfacine) as an add-on therapy for children and adolescents already taking stimulants to treat ADHD, also known as an adjunctive therapy.

The approval was based on a nine-week placebo-controlled study of the drug in which children and adolescents received it in combination with a stimulant.

PHILADELPHIA — The Food and Drug Administration has approved a GlaxoSmithKline drug for a rare blood disorder, GSK said Friday.

The drug maker announced the approval of Promacta (eltrombopag) for chronic immune thrombocytopenic purpura, or ITP, in patients who have not responded adequately to other therapies. Chronic ITP results in increased destruction of inadequate production of platelets in the blood, creating an increased risk of bruising and bleeding.

The FDA granted Promacta orphan drug designation in May 2008 and accelerated approval in November 2008.

DUBLIN — British drug maker Shire again is trying to win approval for a hereditary angioedema drug that the Food and Drug Administration had previously declined to approve.

Shire said Monday that it had submitted a response to the "not approvable letter" the FDA sent to German subsidiary Jerini AG in April 2008 for the drug Firazyr (icatibant).