Content about Mylan

PITTSBURGH — Mylan is getting new headquarters, the company said.

The generic drug maker said it would build a new headquarters near its current one in Southpointe Office Park in Cecil Township, Pa., south of Pittsburgh.

PITTSBURGH — The Food and Drug Administration has given tentative approval to a division of Mylan for a generic drug for treating HIV and AIDS in children in developing countries.

Mylan said Thursday that the FDA had tentatively approved Mylan Labs' abacavir sulfate and lamivudine tablets in the 60 mg/30 mg strength. The drug is a generic version of Viiv Healthcare's Epzicom and was approved under the President's Emergency Plan for AIDS Relief. The drug will only be available for purchase in certain developing countries outside the United States.

PITTSBURGH — Mylan on Friday announced that the company and its subsidiary, Mylan Pharmaceuticals, have resolved the defamation and other related litigation filed by Mylan against the Pittsburgh Post-Gazette and two of its reporters.

"The litigation has been resolved to the satisfaction of both parties," the parties said in a joint statement. "The Post-Gazette did not find and did not intend to report that Mylan had manufactured or distributed any defective drugs. The Post-Gazette regrets if any reader of the article thought otherwise."

PITTSBURGH — Generic drug maker Mylan plans to challenge a court decision that requires it to pay almost $20 million to a drug company whose product it tried to market as a generic.

Sunovion Pharmaceuticals sued Mylan and several subsidiaries in the U.S. District Court for the District of Delaware when the latter sought to market a generic version of Sunovion's Xopenex (levalbuterol hydrochloride) inhalation solution, a drug for asthma and chronic obstructive pulmonary disease. The jury's verdict includes an $18 million award.

WASHINGTON — The generic drug industry's main lobby is hoping Congress will act on a proposed user fee program for generic drugs that it helped negotiate with the Food and Drug Administration.

PITTSBURGH — The Food and Drug Administration has given tentative approval to a generic cholesterol drug made by Mylan, the drug maker said Thursday.

Mylan announced that it had received tentative approval for a generic version of Pfizer's Lipitor (atorvastatin calcium) in the 10-mg, 20-mg, 40-mg and 80-mg strengths.

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

The FDA approved Mylan's levetiracetam extended-release tablets in the 500-mg and 750-mg strengths.

The drug is a generic version of UCB's Keppra XR, used to treat partial onset seizures in epilepsy patients ages 16 years and older.

Various versions of the drug had sales of about $162.8 million during the 12-month period ended in September, according to IMS Health.

PITTSBURGH — The World Health Organization has approved three generic second-line treatments for HIV made by Mylan, the drug maker said Tuesday. The drugs will be delivered to people in developing countries living with HIV and AIDS.

SUPPLIER NEWS — Following the settlement of a patent-litigation suit with Swiss drug maker Novartis over the patch Vivelle-Dot (estradiol transdermal system), a drug for treating symptoms of menopause, Mylan said it had received a patent license to begin selling its version of the drug in December 2013.


The Pittsburgh-based generic drug maker was the first to file for regulatory approval of the drug with the Food and Drug Administration, and as such will be entitled to 180 days of 
market exclusivity.


PITTSBURGH — Mylan said its subsidiary has launched a generic version of a hypertension treatment.

The company said Mylan Pharmaceuticals launched and begun shipping amlodipine besylate and atorvastatin calcium tablets in the 2.5-mg/10-mg; 2.5-mg/20-mg; 2.5-mg/40-mg; 5-mg/10-mg; 5-mg/20-mg; 5-mg/40-mg; 5-mg/80-mg; 10-mg/10-mg; 10-mg/20-mg; 10-mg/40-mg and 10-mg/80-mg strengths. The drug is a generic version of Pfizer's Caduet.

Caduet tablets had U.S. sales of approximately $339 million for the 12 months ended Sept. 30, according to IMS Health.

PITTSBURGH — The Food and Drug Administration has approved a generic drug made by Mylan for cancer patients.

Mylan announced Monday the approval of dexrazoxane for injection, a generic version of Pharmacia & Upjohn's Zinecard. The drug is a chemoprotective agent, used to protect healthy tissue from cancer drugs.

Various versions of the drug had sales of $3.4 million during the 12-month period ended in September, according to IMS Health.

PITTSBURGH — Generic drug maker Mylan has bought rights to a drug delivery platform made by Pfizer that will allow it to make generic versions of two GlaxoSmithKline respiratory drugs, Mylan said Wednesday.