Content about Mylan Inc.

January 2, 2013

Mylan announced that its subsidiary, Mylan Pharmaceuticals, has received final approval from the U.S. Food and Drug Administration for its abbreviated new drug applications for rizatriptan benzoate orally disintegrating tablets and rizatriptan benzoate tablets, generic versions of Merck's Maxalt MLT Tablets and Maxalt Tablets.

PITTSBURGH — Mylan announced that its subsidiary, Mylan Pharmaceuticals, has received final approval from the U.S. Food and Drug Administration for its abbreviated new drug applications for rizatriptan benzoate orally disintegrating tablets, 5 mg and 10 mg, and rizatriptan benzoate tablets, 5 mg and 10 mg. These products are the generic versions of Merck's Maxalt MLT® Tablets and Maxalt® Tablets, respectively, and are indicated for the acute treatment of migraine with or without aura in adults.

December 28, 2012

A federal judge in Washington has dismissed a suit against the FDA brought up by Mylan for withholding approval for the company to sell a generic version of Novartis AG’s heart pill, Diovan.

WASHINGTON — A federal judge in Washington has dismissed a suit against the FDA brought up by Mylan for withholding approval for the company to sell a generic version of Novartis AG’s heart pill, Diovan.

U.S. District Court Judge John D. Bates said in an opinion filed on Dec. 27, that the FDA did not act “capriciously” when it denied Mylan exclusivity to market its version of Diovan. Bates also said Mylan did not show it suffered “irreparable harm” as a result.

August 14, 2012

Drug maker Mylan will pass out free EpiPen injectors to children in schools, the company said Tuesday.

BASKING RIDGE, N.J. — Drug maker Mylan will pass out free EpiPen injectors to children in schools, the company said Tuesday.

Mylan Specialty, the Mylan unit that makes the EpiPen (epinephrine), announced the launch of the EpiPen4Schools program. The program offers four free EpiPen or EpiPen Jr. injectors to public and private school students in kindergarten, elementary, middle and high school, who have valid prescriptions.

August 10, 2012

Mylan has launched a generic drug used to treat sleep disorders, the company said Friday.

PITTSBURGH — Mylan has launched a generic drug used to treat sleep disorders, the company said Friday.

The generic drug maker announced the launch of modafinil tablets in the 100-mg and 200-mg strengths. The drug is a generic version of Provigil, made by Cephalon — a company that Teva Pharmaceutical Industries acquired last year — and used to treat narcolepsy, obstructive sleep apnea and shift work disorder.

August 6, 2012

The Food and Drug Administration has approved several generic versions of a drug used to treat asthma and allergies, the agency said Friday.

SILVER SPRING, Md. — The Food and Drug Administration has approved several generic versions of a drug used to treat asthma and allergies, the agency said Friday.

The FDA announced the approval of montelukast sodium, a drug indicated for controlling asthma symptoms and relieving indoor and outdoor allergies.

The drug is a generic version of Merck's Singulair, which had sales of $4.6 billion in 2011, according to IMS Health.

August 6, 2012

Generic drug maker Mylan has begun commercial operations in India, focusing on drugs to treat HIV and AIDS, the company said Monday.

PITTSBURGH — Generic drug maker Mylan has begun commercial operations in India, focusing on drugs to treat HIV and AIDS, the company said Monday.

The company is launching 18 antiretroviral drugs for HIV/AIDS in India, which has the world's third-largest population of people with the disease, according to the National AIDS Control Organization.

August 3, 2012

Mylan and Gilead Sciences have made an agreement under which Mylan will have rights to produce and market generic versions of Gilead drugs for HIV and AIDS in developing countries.

PITTSBURGH — Mylan and Gilead Sciences have made an agreement under which Mylan will have rights to produce and market generic versions of Gilead drugs for HIV and AIDS in developing countries.

The agreement, involving Gilead and Mylan subsidiary Mylan Labs Ltd., centers around drugs containing emtricitabine, the active ingredient in such drugs as Emtriva, and such fixed-dose combinations as Truvada (emtricitabine and tenofovir disoproxil fumarate) and the experimental Quad.

August 1, 2012

"Buy me some peanuts and Cracker Jacks," goes the line from the famous baseball anthem. For some people, however, that innocuous lyric is a ticket to the hospital, or worse.

PITTSBURGH — "Buy me some peanuts and Cracker Jacks," goes the line from the famous baseball anthem. For some people, however, that innocuous lyric is a ticket to the hospital, or worse.

July 27, 2012

Mylan has launched a generic drug for treating fungal infections, the drug maker said Friday.

PITTSBURGH — Mylan has launched a generic drug for treating fungal infections, the drug maker said Friday.

Mylan announced the launch of itraconazole capsules in the 100-mg strength. The drug is a generic version of Johnson & Johnson's Sporanox, which is used to treat fungal infections that begin in the lungs blatsomycosis, histoplasmosis and aspergillosis in patients who are intolerant of or refractory to amphotericin B therapy. The drug also is used to treat fungal infections in the toenails and fingernails in patients without compromised immune systems.

July 18, 2012

Mylan has settled a patent litigation suit filed by Somaxon Pharmaceutical concerning an insomnia drug, Mylan said.

PITTSBURGH — Mylan has settled a patent litigation suit filed by Somaxon Pharmaceutical concerning an insomnia drug, Mylan said.

The generic drug maker said that under the settlement, it would have the right to sell doxepin hydrochloride tablets in the 3-mg and 6-mg strengths starting in January 2020. The drug is a generic version of Somaxon's Silenor.

July 10, 2012

Generic drug maker Mylan is suing Warner Chilcott and an Australian company, alleging that they illegally tried to protect one of their drugs from generic competition, according to published reports.

NEW YORK — Generic drug maker Mylan is suing Warner Chilcott and an Australian company, alleging that they illegally tried to protect one of their drugs from generic competition, according to published reports.

Reuters reported that Mylan filed a suit against Warner Chilcott and Mayne Pharma Group over the antibiotic and acne drug Doryx (doxycycline), saying they made minor and insignificant changes to the drug so that approval of generic versions would be delayed.

July 3, 2012

Mylan has launched generic versions of two drugs to treat bipolar disorder and allergies, the company said Tuesday.

PITTSBURGH — Mylan has launched generic versions of two drugs to treat bipolar disorder and allergies, the company said Tuesday.

Mylan announced the launch of lithium carbonate extended-release tablets in the 300-mg strength. The drug is a generic version of Noven Therapeutics' Lithobid, various versions of which had sales of about $21 million during the 12-month period ended in March, according to IMS Health.

June 28, 2012

Mylan is challenging the patent protection on a Pfizer drug for treating depression, following an announcement of a similar challenge by Watson made earlier this week.

PITTSBURGH — Mylan is challenging the patent protection on a Pfizer drug for treating depression, following an announcement of a similar challenge by Watson made earlier this week.

Mylan said it had filed for Food and Drug Administration approval of a generic version of Pristiq (desvenlafaxine succinate) extended-release tablets in the 50-mg and 100-mg strengths.

June 28, 2012

Mylan has launched a generic drug for treating thiamine deficiency, the company said Thursday.

PITTSBURGH — Mylan has launched a generic drug for treating thiamine deficiency, the company said Thursday.

The generic drug maker announced the launch of thiamine hydrochloride injection in the 100-mg-per-mL strength, packaged in 25-vial packs of 200-mg-per-2-mL multiple-dose vials.

The drug had sales of about $18.6 million during the 12-month period ended in March, according to IMS Health. Mylan said it would ship the drug immediately.

June 25, 2012

A federal court has ruled against Mylan in a case filed by Teva Pharmaceutical Industries over a drug to treat multiple sclerosis.

PITTSBURGH — A federal court has ruled against Mylan in a case filed by Teva Pharmaceutical Industries over a drug to treat multiple sclerosis.

The U.S. District Court for the Southern District of New York ruled Monday that Mylan's proposed generic version of the drug Copaxone (glatiramer acetate) infringed Teva's patents.

Mylan responded that it was "disappointed" by the decision and would appeal once it had the opportunity to review it in full.

June 21, 2012

The Food and Drug Administration has approved a branded acne drug made by Ranbaxy Labs, the drug maker said. Ranbaxy announced the FDA approval of Absorica (isotretinoin), a drug for treating severe recalcitrant nodular acne.

The Food and Drug Administration has approved a branded acne drug made by Ranbaxy Labs, the drug maker said. Ranbaxy announced the FDA approval of Absorica (isotretinoin), a drug for treating severe recalcitrant nodular acne. The company expects to launch it in the United States in fourth quarter 2012 under an agreement with Canada-based Cipher Pharmaceuticals.


June 19, 2012

Mylan's Canadian subsidiary has launched a new website that is designed to help Canadians learn more about the value, reliability and quality of generic pharmaceuticals.

PITTSBURGH — Mylan's Canadian subsidiary has launched a new website that is designed to help Canadians learn more about the value, reliability and quality of generic pharmaceuticals.

June 8, 2012

Mylan announced that its subsidiary has resolved all disputes with Teva pertaining to the sale of generic versions of a sleep disorder drug.

PITTSBURGH — Mylan announced that its subsidiary has resolved all disputes with Teva pertaining to the sale of generic versions of a sleep disorder drug.

May 29, 2012

Mylan on Tuesday announced that its subsidiary has received final approval from the Food and Drug Administration for its abbreviated new drug application for atorvastatin calcium tablets, a generic version of Pfizer's Lipitor.

PITTSBURGH — Mylan on Tuesday announced that its subsidiary has received final approval from the Food and Drug Administration for its abbreviated new drug application for atorvastatin calcium tablets, a generic version of Pfizer's Lipitor.

The drug maker said Mylan Labs (formerly Matrix Labs) received the go-ahead to market the drug in the 10-mg, 20-mg, 40-mg and 80-mg strengths. Lipitor had U.S. sales of $8.1 billion for the 12 months ended in March, according to IMS Health.

May 29, 2012

A unit of generic drug maker Mylan has settled with Sunovion Pharmaceuticals over a drug used to treat chronic obstructive pulmonary disease and asthma.

PITTSBURGH — A unit of generic drug maker Mylan has settled with Sunovion Pharmaceuticals over a drug used to treat chronic obstructive pulmonary disease and asthma.

Mylan announced Tuesday that it had reached a settlement in a patent litigation suit that Sunovion, which used to operate under the name Sepracor, had filed against Dey Pharma, now known as Mylan Specialty, concerning the drug Xopenex (levalbuterol hydrochloride).

May 23, 2012

A generic antiretroviral drug for treating HIV infection has won approval from the Food and Drug Administration.

PITTSBURGH — A generic antiretroviral drug for treating HIV infection has won approval from the Food and Drug Administration.

Mylan announced Wednesday the approval of nevirapine tablets in the 200-mg strength. The drug is a generic version of Boehringer Ingelheim's Viramune. Mylan plans to begin shipping the drug immediately.

Various versions of the drug had sales of $116.6 million during the 12-month period ended in March, according to IMS Health.

 

May 18, 2012

The Drug Store News Group, the Pharmacist Society and Mylan Inc., one of the world's leading generics and specialty pharmaceutical companies, are pleased to announce an exclusive sponsorship to expand membership opportunities at PharmacistSociety.com – an online forum that supports and enhances professional networks for U.S.-based retail pharmacists, professional organizations and pharmacy companies.

PITTSBURGH and NEW YORK — The Drug Store News Group, the Pharmacist Society and Mylan Inc., one of the world's leading generics and specialty pharmaceutical companies, are pleased to announce an exclusive sponsorship to expand membership opportunities at PharmacistSociety.com — an online forum that supports and enhances professional networks for U.S.-based retail pharmacists, professional organizations and pharmacy companies.

May 17, 2012

The Food and Drug Administration has approved generic versions of one of the country's top-selling drugs made by eight different companies, the agency said Thursday.

SILVER SPRING, Md. — The Food and Drug Administration has approved generic versions of one of the country's top-selling drugs made by eight different companies, the agency said Thursday.

May 14, 2012

A company that makes an emergency treatment for severe allergic reactions is marking the 15th annual Food Allergy Awareness Week.

BASKING RIDGE, N.J. — A company that makes an emergency treatment for severe allergic reactions is marking the 15th annual Food Allergy Awareness Week.

Mylan Specialty, a division of drug maker Mylan, said it would support various initiatives to raise awareness of life-threatening food allergies during the special week, which started Sunday and ends Saturday. Mylan Specialty is the maker of EpiPen (epinephrine), used to treat anaphylaxis, a severe allergic reaction that can occur quickly and without warning.

May 10, 2012

Mylan has increased its 2012 earnings per share guidance range, the generic drug maker said.

PITTSBURGH — Mylan has increased its 2012 earnings per share guidance range, the generic drug maker said.

The company boosts its EPS guidance range to $2.45 to $2.55 in adjusted diluted earnings per share, up from $2.30 to $2.50 per share. All of Mylan's other 2012 guidance metrics remain unchanged.

In related news, Mylan also announced that its board of directors has approved the repurchase of up to $500 million of the company's common stock in the open market.