Content about Mylan

PITTSBURGH — Mylan has launched a generic treatment for breast cancer, the drug maker said Monday.

Mylan announced the launch of letrozole tablets in the 2.5-mg strength, an adjuvant treatment for postmenopausal women with hormone receptor-positive early-stage breast cancer.

The drug is the first generic version of Novartis’ Femara, which had sales of about $682 million in 2010, according to IMS Health.

PITTSBURGH — Mylan subsidiary Bioniche Pharma has launched an injectable treatment for a rare metabolic disorder, Mylan said Tuesday.

Mylan announced the launch of octreotide acetate injection in prefilled syringes, a generic version of Novartis’ Sandostatin, used to treat the disorder acromegaly and suppress or inhibit severe diarrhea related to certain tumors. Acromegaly results from excess growth hormone produced in the pituitary gland, causing fatigue and weakness, body odor and carpal tunnel syndrome.

PITTSBURGH — Though more than 7-in-10 drugs dispensed in the United States today are generics, and the Food and Drug Administration holds generics to the same standards as branded drugs, misgivings among the general public still exist, fed by the occasional media report of patients experiencing bad side effects after taking certain generic drugs.

PITTSBURGH — A subsidiary of Mylan has won approval to sell a generic drug for HIV and AIDS in developing countries under the President’s Emergency Plan for AIDS Relief.

Mylan announced Thursday that Matrix Labs won Food and Drug Administration approval for zidovudine tablets in the 100-mg strength. The drug is a generic version of ViiV Healthcare’s Retrovir, an antiretroviral sold as a water-dispersible tablet. The drug is designed to treat HIV and AIDS in children and prevent transmission of the virus from pregnant mothers to their children.

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.

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.

CHADDS FORD, Pa. — Mylan has announced its intention to market a version of a painkiller made by Endo Pharmaceuticals and partner company Teikoku Seiyaku ahead of patent expiration.

Endo said Monday that Teikoku Seiyaku and U.S. subsidiary Teikoku Pharma USA had received a Paragraph IV certification from Mylan stating the latter’s intention to market a generic lidocaine topical patch. The drug is a generic version of Endo’s and Teikoku’s Lidoderm.

PITTSBURGH — A Mylan subsidiary has inked a nonexclusive license agreement with Tibotec Pharmaceuticals to manufacture, market and distribute a generic version of an HIV treatment.

Pending the regulatory approval of TMC278 (rilpivirine hydrochloride), Matrix Labs will have the right to manufacture once-daily 25-mg TMC278 as a single-agent medicine and a fixed-dose combination product, Mylan said. Matrix also will be able to market the drug in sub-Saharan Africa, certain developing countries and India.

PITTSBURGH — The Food and Drug Administration has approved a treatment for gastroesphageal reflux disease made by a subsidiary of Mylan, the generic drug maker said Monday.

The FDA approved Matrix Labs’ pantoprazole sodium delayed-release tablets in the 20-mg and 40-mg strengths.

The drug is a version of Protonix DR, made by Wyeth, now part of Pfizer. Various versions of the drug had sales of around $1.7 billion during the 12-month period ended in September, according to IMS Health. The FDA also approved a version made by Dr. Reddy’s Labs on Friday.

PITTSBURGH — The Food and Drug Administration has given tentative approval to an antiretroviral treatment for children with HIV and AIDS under the President’s Emergency Plan for AIDS Relief program.

Mylan announced Thursday that its subsidiary, Matrix Labs, had received the tentative approval for lamivudine and zidovudine tablets in the 30-mg/60-mg strength. The drug is a generic version of Combivir, made by ViiV Healthcare, a company specializing in HIV and AIDS created as a partnership between Pfizer and GlaxoSmithKline.

Supplier News — The Food and Drug Administration has approved a generic drug for hypertension made by Mylan. Mylan announced the approval of nifedipine extended-release tablets in the 30-mg, 60-mg and 90-mg strengths. The drug is a generic version of Bayer’s Adalat CC. Nifedipine tablets had sales of around $82 million during the 12-month period ended June 2010, according to IMS Health.



DEERFIELD, Ill., and OSAKA, Japan — Takeda and its subsidiary settled the patent suits it brought against generic drug makers that sought to develop their own versions of its diabetes treatment.