Content about Mylan

May 3, 2011

Sales at generic drug maker Mylan increased by 12% during first quarter 2011, compared with first quarter 2010, the company said Tuesday.

PITTSBURGH — Sales at generic drug maker Mylan increased by 12% during first quarter 2011, compared with first quarter 2010, the company said Tuesday.

Sales for the three months ended March 31 were $1.45 billion, compared with $1.29 billion during the same period a year ago. Profits, meanwhile, were $104.2 million, compared with $61.1 million in first quarter 2010.

April 25, 2011

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

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.

April 20, 2011

Mylan has launched a generic drug for treating herpes, the company said Wednesday.

PITTSBURGH — Mylan has launched a generic drug for treating herpes, the company said Wednesday.

Mylan announced the launch of famciclovir tablets in the 125-mg, 250-mg and 500-mg strengths. The drug is a generic version of Novartis’ Famvir.

Branded and generic versions of the drug had sales of $196 million in 2010, according to IMS Health.

April 5, 2011

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

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.

April 4, 2011

The Food and Drug Administration has approved a generic drug made by Mylan that reduces pressure in the eye, Mylan said Monday.

PITTSBURGH — The Food and Drug Administration has approved a generic drug made by Mylan that reduces pressure in the eye, Mylan said Monday.

Mylan announced the approval of latanoprost ophthalmic solution in the 0.005% strength. The drug is a generic version of Xalatan, made by Pharmacia and Upjohn, now part of Pfizer.

Various versions of the drug had sales of around $711 million in 2010, according to IMS Health.

March 23, 2011

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 — 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.

March 21, 2011

Generic drug maker Mylan is suing the Food and Drug Administration in an effort to prevent Gurgaon, India-based competitor Ranbaxy Labs from launching its generic version of Pfizer’s cholesterol medication Lipitor, according to published reports.

NEW YORK — Generic drug maker Mylan is suing the Food and Drug Administration in an effort to prevent Gurgaon, India-based competitor Ranbaxy Labs from launching its generic version of Pfizer’s cholesterol medication Lipitor, according to published reports.

March 10, 2011

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.

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.

March 4, 2011

SUPPLIER NEWS — Impax Labs received regulatory approval from the Food and Drug Administration for its generic version of a bacterial infection treatment. The drug maker said the FDA approved its 150-mg doxycycline monohydrate capsules, a drug used to treat bacterial infections and a generic version of Adoxa, made by Nycomed subsidiary PharmaDerm. The 150-mg strength of Adoxa had sales of about $25 million during the 12 months ended in December 2010, according to Wolters Kluwer.

March 2, 2011

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 — 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.

March 1, 2011

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

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.

February 28, 2011

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

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.

February 15, 2011

Mylan has launched a generic drug for fungal infections, the company said Tuesday.

PITTSBURGH — Mylan has launched a generic drug for fungal infections, the company said Tuesday.

Mylan announced the launch, through subsidiary Mylan Pharmaceuticals, of voriconazole tablets in the 50-mg and 200-mg strengths. The drug is a triazole antifungal agent.

The tablets are a generic version of Pfizer’s Vfend, which had sales of $186 million in 2010, according to IMS Health. Mylan launched its version of the drug under a settlement with Pfizer.

January 31, 2011

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.

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.

January 28, 2011

The Food and Drug Administration has approved a generic hypertension treatment made by Mylan.

PITTSBURGH — The Food and Drug Administration has approved a generic hypertension treatment made by Mylan.

Mylan announced the approval Friday of nisoldipine extended-release tablets in the 8.5-mg, 17-mg, 25.5-mg and 34-mg strengths. The drug is a generic version of Shionogi Pharma’s Sular, which had sales of about $103 million during the 12-month period ended in September 2010, according to IMS Health.

January 27, 2011

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

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.

January 25, 2011

Generic drug maker Mylan has entered settlements with Pfizer concerning two drugs for treating cholesterol.

PITTSBURGH — Generic drug maker Mylan has entered settlements with Pfizer concerning two drugs for treating cholesterol.

Mylan announced Tuesday that it had settled patent litigation suits with Pfizer concerning Lipitor (atorvastatin calcium) and Caduet (atorvastatin calcium and amlodipine besylate).

Under the Caduet agreement, the lawsuit will be dismissed, and Mylan can launch its generic version on Nov. 30. Terms of the Lipitor agreement remain confidential.

January 24, 2011

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.

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.

January 20, 2011

Mylan subsidiary Dey Pharma has launched a mobile application for patients at risk of severe allergic reactions, which is tied to its EpiPen product.

BASKING RIDGE, N.J. — Mylan subsidiary Dey Pharma has launched a mobile application for patients at risk of severe allergic reactions, which is tied to its EpiPen product.

The MyEpiPen app is available for the Apple iPhone, iPod Touch and iPad, and allows individuals, parents, guardians and others to create and share profiles of severe allergies with friends, family, teachers, school nurses, babysitters and others. Other features include an instructional video, user guide and others.

January 20, 2011

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.

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.

January 18, 2011

The Food and Drug Administration has approved a generic diabetes drug made by Mylan, the drug maker said Tuesday.

PITTSBURGH — The Food and Drug Administration has approved a generic diabetes drug made by Mylan, the drug maker said Tuesday.

Mylan announced the approval of acarbose tablets in the 25-mg, 50-mg and 100-mg strengths. The drug is a version of Bayer’s Precose, used with diet and exercise to improve glycemic control in adults with Type 2 diabetes.

The drug had sales of around $23 million during the 12-month period ended in September, according to IMS Health.

January 5, 2011

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.



 

January 4, 2011

Generic drug maker Mylan has settled a lawsuit concerning Medicaid reimbursements with the federal government and the state of Texas, Mylan said Dec. 24.

PITTSBURGH — Generic drug maker Mylan has settled a lawsuit concerning Medicaid reimbursements with the federal government and the state of Texas, Mylan said Dec. 24.

Under the settlement, Mylan will pay $65 million.

Several state attorneys general filed lawsuits against Mylan and other drug companies in September 2003 over Medicaid reimbursements, alleging that the companies defrauded the programs by reporting average wholesale prices greater than the prices of their prescription drugs, thus causing the programs to make excessive payments to healthcare providers.

December 22, 2010

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.

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.

December 21, 2010

A judge recently blocked AstraZeneca from attempting to impede the development of generic versions of its popular cholesterol drug, according to published reports.

NEW YORK — A judge recently blocked AstraZeneca from attempting to impede the development of generic versions of its popular cholesterol drug, according to published reports.