Content about Mylan

PITTSBURGH — Mylan's India-based subsidiary is changing its name, Mylan said Wednesday.

The generic drug maker announced that Matrix Labs, based in Hyderabad, India, had formally changed its name to Mylan Labs.

"We are pleased to complete the name change from Matrix to a Mylan company and are excited to operate in India under one powerful brand," Mylan chairman and CEO Robert Coury said.

Mylan acquired Matrix in 2006.

SUPPLIER NEWS — The Food and Drug Administration has approved Mylan’s promethazine hydrochloride tablets, a generic drug for treating allergies, in the 12.5-mg, 25-mg and 50-mg strengths. Promethazine hydrochloride tablets, which are manufactured by several companies, had sales of about $42 million during the 12-month period ended in June, according to IMS Health.


NEW YORK — Mylan may have to pay $77 million to four health insurers over allegations that it sought to control the market on ingredients used for two anti-anxiety medicines, according to published reports.

Bloomberg reported that the Supreme Court rejected the drug maker's appeal of a 2005 jury verdict in a case that involved antitrust allegations regarding the drugs lorazepam and clorazepate.

DUBLIN — A federal court in New Jersey has blocked an attempt by Mylan to market a generic version of a drug made by Warner Chilcott.

Warner Chilcott announced Thursday that the U.S. District Court for the District of New Jersey granted its motion for a preliminary injunction against Mylan to prevent it from launching a generic version of the antibiotic Doryx (doxycycline) in the 150-mg strength until the court makes a decision relating to a patent covering the drug, which Warner Chilcott and Mayne Pharmaceuticals allege Mylan to have infringed.

PITTSBURGH — Mylan subsidiary Matrix Labs has received tentative approval from the Food and Drug Administration for its new drug application of a co-packaged antiretroviral treatment under the President's Emergency Plan for AIDS Relief.

JERUSALEM — A federal court has acted in favor of Teva Pharmaceutical Industries in the drug maker's patent infringement case against several generic drug companies seeking to market versions of its multiple sclerosis drug.

PITTSBURGH — Mylan announced Wednesday that it filed with the Food and Drug Administration for approval of a generic version of a drug for migraine headaches made by Endo Pharmaceuticals.

Mylan said it was the first to file for approval of a generic version of Frova (frovatriptan succinate EQ) tablets in the 2.5-mg strength. In response, Endo has filed a patent infringement lawsuit against Mylan in response to the filing.

Frova had sales of $68.2 million during the 12-month period ended in June, according to IMS Health.

PITTSBURGH — Mylan subsidiary Matrix Labs has expanded its licensing agreement with Gilead Sciences.

Under the new terms, Mylan said that Matrix has the rights to produce and market generic versions of three Gilead HIV/AIDS therapies — elvitegravir, an investigational integrase inhibitor; cobicistat, an investigational antiretroviral boosting agent; and the “quad,” a once-daily, single-tablet combination of four separate Gilead medicines — if and when the drugs receive regulatory approval.

PITTSBURGH — A generic drug made by Mylan for Crohn’s disease does not infringe on the patent for the branded drug, a federal court ruled Thursday.

Mylan said the U.S. District Court for the District of Delaware ruled that Mylan’s regulatory approval application for budesonide capsules in the 3-mg strength does not violate the patent for the branded drug, AstraZeneca’s Entocort EC.

SUPPLIER NEWS — A generic drug maker has been granted approval from the Food and Drug Administration to manufacture its version of a urinary tract infection treatment. Amneal Pharmaceuticals said that its nitrofurantoin oral suspension in the 25-mg/5-mL strength is the first-to-market generic version of Furadantin, made by Shionogi Pharma. Amneal will sell its generic in 8-oz. (230-mL) size bottles, the company said. Annual U.S. sales of nitrofurantoin oral suspension totaled $40 million for the year ended in January, according to IMS Health data.


PITTSBURGH — The Food and Drug Administration has approved a generic drug for depression and anxiety made by Mylan, the drug maker said Thursday.

Mylan announced the approval of venlafaxine hydrochloride extended-release capsules in the 37.5-mg, 75-mg and 150-mg strengths.

The drug, used to treat major depressive disorder and social anxiety disorder, is a generic version of Effexor XR, made by Wyeth. Mylan is launching the drug under a licensing agreement it made with Wyeth before its purchase by Pfizer.