Content about Mylan

May 21, 2013

Court upholds Mylan's patents on COPD drug

A federal appellate court has ruled in favor of Mylan in a case involving a drug for chronic obstructive pulmonary disease, the drug maker said.

PITTSBURGH — A federal appellate court has ruled in favor of Mylan in a case involving a drug for chronic obstructive pulmonary disease, the drug maker said Tuesday.

Mylan said that the Court of Appeals for the Federal Circuit had reversed a lower court's decision invalidating five patents held by subsidiary Mylan Specialty for Perforomist (formoterol fumarate) in a case filed in 2007 against Dainippon Sumitomo Pharma subsidiary Sunovion Pharmaceuticals over the drug Brovana (arformoterol tartrate).

May 21, 2013

Mylan hires Julie Bowen in anaphylaxis campaign

A subsidiary of drug maker Mylan is sponsoring a campaign to draw attention to severe allergic reactions.

BASKING RIDGE, N.J. — A subsidiary of drug maker Mylan is sponsoring a campaign to draw attention to severe allergic reactions.

Mylan Specialty announced the Raise Your Hand for Anaphylaxis Awareness campaign, hiring actress Julie Bowen as a celebrity spokeswoman. The campaign will invite people to virtually "raise their hands" for their school districts by visiting www.Anaphylaxis101.com; four winning school districts will receive grants of $15,000 to support educational programs.

May 17, 2013

Mylan launches cholesterol drug

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

PITTSBURGH — Mylan has launched a generic drug for treating cholesterol, the company said Friday.

Mylan announced the launch of fenofibrate tablets in the 48 mg and 145 mg strengths. The drug is used to reduce so-called "bad" low-density lipoprotein cholesterol, total cholesterol, triglycerides and apolipoprotein B while increasing "good" high-density lipoprotein cholesterol in adults with primary hyperocholesterolemia or mixed dyslipidemia.

May 15, 2013

FDA approves Mylan migraine drug

The Food and Drug Administration has approved a generic migraine drug made by Mylan, the company said Wednesday.

PITTSBURGH — The Food and Drug Administration has approved a generic migraine drug made by Mylan, the company said Wednesday.

Mylan announced the approval of zolmitriptan tablets in the 2.5 mg and 5 mg strengths. The drug maker plans to launch the product immediately.

The drug is a generic version of IPR Pharmaceuticals' Zomig and is used for the acute treatment of migraine in adults. Various versions of the drug had sales of $152.8 million during the 12-month period that ended in March, according to IMS Health.

April 25, 2013

Mylan marks 25th anniversary of EpiPen's approval by giving it away for free

Mylan Specialty announced Thursday the introduction of a "$0 Co-Pay Offer" on a product used to treat severe allergic reactions.

BASKING RIDGE, N.J. — Mylan Specialty announced Thursday the introduction of a "$0 Co-Pay Offer" on a product used to treat severe allergic reactions.

The drug maker is offering a co-pay card to patients with or without insurance for the EpiPen in recognition of the 25th anniversary of its approval by the Food and Drug Administration. The co-pay card is available online at EpiPen.com, and the offer will expire on Dec. 31.

April 5, 2013

Actavis to market, distribute authorized generic version of Valeant drug; Valeant to co-promote Actavis drug

Actavis will market and distribute an authorized generic version of a genital herpes ointment made by Valeant Pharmaceuticals International, the companies said Friday.

PARSIPPANY, N.J. — Actavis will market and distribute an authorized generic version of a genital herpes ointment made by Valeant Pharmaceuticals International, the companies said Friday.

The agreement centers around Zovirax, known generically as acyclovir, in the 5% strength. The Food and Drug Administration approved the generic version, made by Mylan, on Wednesday. Financial terms of the deal were not disclosed.

April 4, 2013

Valeant earnings per share could take hit in 2013 from herpes ointment generic

The Food and Drug Administration approval this week of a generic genital herpes ointment made by Mylan could make a slight dent in the stock price of the company that makes the branded version.

MONTREAL — The Food and Drug Administration approval this week of a generic genital herpes ointment made by Mylan could make a slight dent in the stock price of the company that makes the branded version.

Canada-based Valeant Pharmaceuticals International said that while it expected Mylan to receive approval for a generic version of Zovirax (acyclovir) ointment, it did not include the approval in its original budget expectations and thus expected its earnings per share in fiscal year 2013 to be reduced by 30 to 40 cents.

April 3, 2013

FDA approves Mylan genital herpes ointment

The Food and Drug Administration has approved a new drug for genital herpes made by Mylan, the drug maker said.

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

Mylan announced the approval of acyclovir ointment in the 5% strength. The drug is a generic version of Valeant International's Zovirax, used to manage initial genital herpes and in limited, non-life-threatening mucocutaneous herpes simplex virus infections in patients with compromised immune systems.

March 18, 2013

FDA approves Mylan bronchospasm drug

The Food and Drug Administration has approved a generic treatment for bronchospasm made by Mylan, the drug maker said Monday.

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

Mylan announced the approval of levalbuterol inhalation solution in the 0.31 mg/3 mL, 0.63 mg/3 mL and 1.25 mg/3 mL strengths. The company has begun shipping the product.

The drug is a generic version of Sunovion's Xopenex inhalation solution, which is used to treat bronchospasm in patients ages 6 years and older with reversible obstructive airway disease.

March 14, 2013

Mylan can launch generic diabetes drug in August

Mylan has settled a patent-infringement lawsuit filed by Shionogi over its generic version of a drug for diabetes, Mylan said.

PITTSBURGH — Mylan has settled a patent-infringement lawsuit filed by Shionogi over its generic version of a drug for diabetes, Mylan said.

The generic drug maker said that under the agreement, it can launch a generic version of Shionogi's Fortamet (metformin hydrochloride) extended-release tablets in the 500-mg and 1,000-mg strengths on Aug. 1.

Metformin hydrochloride extended-release tablets in those two strengths had sales of about $125 million during the 12-month period that ended in September, according to IMS Health.

February 28, 2013

Mylan acquires Indian injectables maker

Mylan has bought a manufacturer of generic injectables for $1.6 billion, the company said.

PITTSBURGH — Mylan has bought a manufacturer of generic injectables for $1.6 billion, the company said.

Mylan announced the acquisition of Bangalore, India-based Agila from Strides Arcolab, which Mylan said would allow it to strengthen its injectables business and enter new markets around the world.

February 28, 2013

Mylan posts double-digit growth in 2012

Mylan had sales of $1.72 billion in fourth-quarter 2012 and $6.8 billion for fiscal year 2012, the generic drug maker said.

PITTSBURGH — Mylan had sales of $1.72 billion in fourth-quarter 2012 and $6.8 billion for fiscal year 2012, the generic drug maker said.

Those figures compared with $1.53 billion in fourth-quarter 2011 and $6.13 billion for fiscal year 2011.

The latest sales figures include $1.58 billion in generics sales and $155.1 million in branded drug sales.

"2012 was an outstanding year for Mylan, with top-line growth of 11% and bottom-line growth of 27% versus last year," Mylan CEO Heather Bresch said.

February 25, 2013

Mylan ships cholesterol drug

Mylan has begun shipping a generic drug for cholesterol, the company said Monday.

PITTSBURGH — Mylan has begun shipping a generic drug for cholesterol, the company said Monday.

Mylan said a subsidiary had started shipping fenofibrate capsules in the 43-mg and 130-mg strengths. The drug is a generic version of Lupin Atlantis Holdings Antara, used in combination with diet to reduce elevated bad cholesterol and other blood lipids and increase beneficial HDL cholesterol in patients with primary hypercholesterolemia or mixed dyslipidemia.

February 20, 2013

Mylan distributes EpiPens to thousands of schools

A division of drug maker Mylan has distributed auto-injectors of an emergency drug used for severe allergic reactions to schools nationwide.

BASKING RIDGE, N.J. — A division of drug maker Mylan has distributed autoinjectors of an emergency drug used for severe allergic reactions to schools nationwide.

Mylan Specialty said Wednesday that since its August 2012 launch of the EpiPen4Schools program, thousands of schools around the country had elected to participate and receive free EpiPen and EpiPen Jr (epinephrine) auto-injectors. The program was launched to help schools have improved access to epinephrine in the event that a person experiences a life-threatening allergic reaction, also known as anaphylaxis.

February 19, 2013

Mylan, Biocon enter deal on generic analog insulins

Mylan and Biocon have a deal to develop and sell generic insulin-analog products for diabetes, Mylan said.

PITTSBURGH — Mylan and Biocon have a deal to develop and sell generic insulin-analog products for diabetes, Mylan said.

Under the deal, Mylan will have the rights to develop and market Biocon's Glargine, Lispro and Aspart, respectively generic versions of Sanofi's Lantus, Eli Lilly's Humalog and Novo Nordisk's NovoLog.

February 11, 2013

Mylan appoints two new board members

Mylan has appointed its president and a former partner at Goldman Sachs to its board of directors, the generic drug maker said.

PITTSBURGH — Mylan has appointed its president and a former Goldman Sachs & Co. partner to its board, the generic drug maker said Monday.

Mylan announced the appointment of president Rajiv Malik and former Goldman Sachs partner Melina Higgins to its board.

January 2, 2013

FDA approves Mylan's generic Maxalt MLT tablet

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

FDA approves Mylan's generic Dilantin chewable tablets

Mylan on Friday announced that its subsidiary, Mylan Pharmaceuticals, has received final approval from the U.S. Food and Drug Administration for its phenytoin chewable tablets USP in the 50 mg strength.

PITTSBURGH — Mylan on Friday announced that its subsidiary, Mylan Pharmaceuticals, has received final approval from the U.S. Food and Drug Administration for its phenytoin chewable tablets USP in the 50 mg strength.

The product is a generic version of Pfizer's Dilantin Chewable Tablets, which are indicated for the control of generalized tonic-clonic (i.e., grand mal) and complex partial (i.e., psychomotor, temporal lobe) seizures, and prevention and treatment of seizures occurring during or following neurosurgery.

December 28, 2012

Mylan generic heart drug suit against FDA dismissed

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.

December 28, 2012

Mylan launches new generic oral contraceptive

Mylan on Friday announced that its partner Famy Care has received final approval from the Food and Drug Administration for its abbreviated new drug application for levonorgestrel and ethinyl estradiol Tablets USP in the 0.15mg/0.03mg strength.

PITTSBURGH — Mylan on Friday announced that its partner Famy Care has received final approval from the U.S. Food and Drug Administration for its abbreviated new drug application for levonorgestrel and ethinyl estradiol tablets USP in the 0.15mg/0.03mg strength.

The product is a generic version of Teva Branded Pharmaceutical Products' Nordette 28 Tablets, a form of oral contraception. The new product will be distributed in the United States by Mylan Pharmaceuticals, and the company is shipping the product immediately.

December 20, 2012

Mylan, Orion settle Parkinson's disease drug case

Generic drug maker Mylan has settled with Orion over a drug used to treat Parkinson's disease, Mylan said Thursday

PITTSBURGH — Generic drug maker Mylan has settled with Orion over a drug used to treat Parkinson's disease, Mylan said Thursday.

The company said it reached a settlement with Orion to resolve patent litigation concerning a generic version of Orion's drug Comtan (entacapone) tablets in the 200-mg strength. The drug is used with levodopa-carbidopa therapy to treat Parkinson's patients who experience signs and symptoms of end-of-dose "wearing off."

December 18, 2012

FDA approves generic malaria drug

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

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

Mylan announced the approval of quinine sulfate capsules in the 324-mg strength and has begun shipping it. The drug is a generic version of Mutual Pharmaceutical's Qualaquin and is used to treat uncomplicated Plasmodium falciparum malaria.

Various versions of the drug had sales of about $31.9 million during the 12-month period ended in September 2012, according to IMS Health.

December 7, 2012

Mylan launches generic hypertension drug

The Food and Drug Administration has approved a generic hypertension drug made by Mylan, the company said.

PITTSBURGH — The Food and Drug Administration has approved a generic hypertension drug made by Mylan, the company said.

Mylan announced the approval and launch of candesartan cilexetil and hydrochlorothiazide tablets in the 16/12.5-mg, 32/12.5-mg and 32/25-mg strengths. Mylan said it was the first company to submit a complete regulatory approval application for the drug and is thus entitled to 180 days of market exclusivity in which to compete directly with the branded version.

November 29, 2012

FDA approves Mylan overactive bladder drug

The Food and Drug Administration approved a new generic drug made by Mylan for urinary disorders, the company said Thursday.

PITTSBURGH — The Food and Drug Administration approved a new generic drug made by Mylan for urinary disorders, the company said Thursday.

Mylan announced the approval and launch of tolterodine tartrate tablets in the 1-mg and 2-mg strengths. The drug is a generic version of Detrol, made by Pharmacia and Upjohn, now owned by Pfizer.

Used to treat overactive bladder, tolterodine tartrate tablets had sales of about $61.5 million during the 12-month period ended in September, according to IMS Health.

November 15, 2012

Generic drugs compete in game of differentiation

The year 2012 is coming to an end, and it’s been a big year for  generic drugs. 