Content about Mylan

BASKING RIDGE, N.J. — A Mylan subsidiary has settled a lawsuit brought on by the Department of Justice four years ago.

PITTSBURGH — The Food and Drug Administration has given tentative approval to a generic drug for HIV/AIDS made by Mylan subsidiary Matrix Labs for distribution in developing countries under the President’s Emergency Plan for AIDS Relief, Mylan said Tuesday.

The tentative approval under PEPFAR covers Matrix’s abacavir sulfate tablets in the 60-mg strength. The drug is a generic version of ViiV Healthcare’s Ziagen, and is used to treat the disease in children.

WALTHAM, Mass. — William Gibson, the science-fiction author who helped create the cyberpunk genre in the 1980s and paved the way for “The Matrix” movie franchise, once said, “The future is already here—it’s just not evenly distributed.”

He was correct. Emerging technologies, ranging from computers to mobile phones, historically have migrated from the theoretical to the inaccessible to the aristocratic to the indispensable and finally to the mundane.

PITTSBURGH The Food and Drug Administration has approved a Mylan generic drug for Parkinson’s disease, Mylan said Thursday.

The drug maker announced the approval of pramipexole dihydrochloride tablets in the 0.125-mg, 0.25-mg, 0.5-mg, 1-mg and 1.5-mg strengths. The drug is a generic version of Boehringer Ingelheim’s Mirapex.

PITTSBURGH The Food and Drug Administration has approved two generic drugs by Mylan for treating hypertension, Mylan said Friday.

The company announced the approval of losartan potassium and hydrochlorothiazide tablets in the 50/12.5-mg and 100/25-mg strengths, and losartan potassium tablets in the 25-mg, 50-mg and 100-mg strengths, generic versions of Merck’s Hyzaar and Cozaar, respectively. Mylan began marketing its version of Hyzaar in the 100/12.5-mg strength in April.

PITTSBURGH The Food and Drug Administration has approved a generic chemotherapy drug made by Mylan.

The Pittsburgh-based drug maker said Monday that it had received approval for the injected drug fludarabine phosphate in the 25-mg-per-mL strength. The FDA determined the drug to be therapeutically equivalent to Teva Parenteral’s fludarabine phosphate.

PITTSBURGH The Food and Drug Administration has approved a generic treatment for organ transplant patients.

Mylan announced Tuesday the approval of tacrolimus capsules in the 0.5-mg, 1-mg and 5-mg strengths, and said it plans to launch the drug immediately. The drug is used to prevent rejection of transplanted organs.

PITTSBURGH Mylan has launched a generic treatment for acne, the company said Thursday.

Mylan announced the launch of minocycline hydrochloride extended-release tablets in the 45 mg, 90 mg and 135-mg strengths. The drug is a generic version of Solodyn ER, made by Medicis Pharmaceuticals Corp.

Minocycline ER had sales of around $496 million during the 12-month period ended in March, according to IMS Health.

PITTSBURGH The Food and Drug Administration has approved a generic arthritis treatment made by Mylan, the drug maker said Wednesday.

The FDA approved nabumetone tablets, a treatment for osteoarthritis and rheumatoid arthritis, in the 500 mg and 750-mg strengths.