Generics

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.

ST. LOUIS — Patients who take generic antidepressants will remain as adherent as those who take brand-name drugs to treat the condition, according to a new study.

The study, conducted by Express Scripts and published in the Journal of Managed Care Pharmacy, found patients starting generic selective serotonin reuptake inhibitors and generic selective norepinephrine reuptake inhibitors had a discontinuation rate of 44.2%, compared with 46.8% among those on brand-name SSRIs and SNRIs.

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).

PITTSBURGH — Mylan's board of directors now includes the drug maker's president.

Mylan said its board of directors now includes Mylan president Heather Bresch and Robert Cindrich, who currently serves as senior adviser to the office of the president at the University of Pittsburgh Medical Center, a global health enterprise.

With the additions of Bresch and Cindrich, Mylan's board now has 11 members.

PITTSBURGH — The Food and Drug Administration has approved a treatment for shingles made by a subsidiary of generic drug maker Mylan.

Mylan announced Monday the approval of Matrix Labs’ gabapentin capsules in the 100-mg, 300-mg and 400-mg strengths. The drug is used to treat postherpetic neuralgia, a painful complication of shingles.

Gabapentin capsules had sales of about $300 million in 2010, according to IMS Health.

PHILADELPHIA — Watson Labs is hoping to be the first to market a generic version of a popular drug for attention deficit hyperactivity disorder.

British drug maker Shire announced Thursday that it had received notification that Watson filed for regulatory approval of a version of Adderall XR (dextroamphetamine and amphetamine) capsules with the Food and Drug Administration. Watson’s application contained a Paragraph IV certification, a legal assertion that the patent covering Adderall XR is invalid, unenforceable or won’t be infringed by Watson’s product.

WOODCLIFF LAKE, N.J. — Generic drug maker Par Pharmaceutical Cos. had sales of $227 million during fourth quarter 2010 and $1 billion for the year as a whole, according to an earnings statement Thursday.

Profits were $17.5 million for the quarter and $92.7 million for the year, compared with $10.7 million in fourth quarter 2009 and $76.9 million for 2009 as a whole.