Branded

DARMSTADT, Germany — The Food and Drug Administration declined to approve a Merck KGaA drug designed to treat relapsing-remitting multiple sclerosis.

ALEXANDRI, Va. — In a letter penned Thursday by the National Association of Chain Drug Stores to Sen. Olympia Snowe, R-Maine, the association stated that while it shares the goal of reducing prescription drug costs, authorizing the reimportation of prescription medications — as sought in S.319, the Pharmaceutical Market Access and Drug Safety Act of 2011 — raises concerns about patient health and safety.

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.

PITTSBURGH — A group of drug makers have sued Mylan over its attempt to gain Food and Drug Administration approval for a generic menopause drug, Mylan said Tuesday.

SILVER SPRING, Md. — The Food and Drug Administration has taken action against makers of prescription drugs for cough-cold and allergies that don’t have regulatory approval, the agency said Wednesday.

The action is part of the agency’s Unapproved Drugs Initiative, which seeks to remove from the market drugs that have not received approval. In many cases, the drugs were marketed before the FDA adopted its current regulatory standards.

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.

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.