Content about Mylan

November 14, 2013

New legislation signed into law Wednesday encourages states to adopt laws allowing schools to maintain a supply of emergency treatments for life-threatening allergy attacks.

NEW YORK — New legislation signed into law Wednesday encourages states to adopt laws allowing schools to maintain a supply of emergency treatments for life-threatening allergy attacks.

Barack Obama signed the School Access to Emergency Epinephrine Act, under which schools could maintain a supply of epinephrine, which is the only first-line treatment for life-threatening allergic reactions, also known as anaphylaxis.

The legislation received praise from Mylan, a drug maker that produces EpiPen, a popular epinephrine injector pen.

November 11, 2013

Mylan has launched its generic version of a drug used to treat gastroesophageal reflux disease, the U.S.-based generic drug maker said Monday.

PITTSBURGH — Mylan has launched its generic version of a drug used to treat gastroesophageal reflux disease, the U.S.-based generic drug maker said Monday.

Mylan announced the launch of rabeprazole sodium extended-release tablets in the 20-mg strength, a generic version of Eisai's Aciphex. The Food and Drug Administration approved generic versions of Aciphex made by six companies on Friday.

Aciphex had sales of about $830.1 million during the 12-month period that ended in September, according to IMS Health. 

November 5, 2013

The Food and Drug Administration has approved a generic drug made by Mylan for treating overactive bladder, according to agency records.

SILVER SPRING, Md. — The Food and Drug Administration has approved a generic drug made by Mylan for treating overactive bladder, according to agency records.

The FDA approved Mylan's tolterodine tartrate extended-release capsules in the 2-mg and 4-mg strengths.

The drug is a generic version of Pfizer's Detrol LA. Detrol LA has annual sales of about $700 million, according to published reports.

 

November 1, 2013

Mylan expects to be the first to market with a generic version of a drug for treating patients with gout, the company said Friday, though its filing has triggered a lawsuit from the makers of the branded version.

PITTSBURGH — Mylan expects to be the first to market with a generic version of a drug for treating patients with gout, the company said Friday, though its filing has triggered a lawsuit from the makers of the branded version.

October 31, 2013

Mylan experienced a slight dip in sales in its third quarter, due primarily to fluctuating currency values, the generic drug maker said Thursday.

PITTSBURGH — Mylan experienced a slight dip in sales in its third quarter, due primarily to fluctuating currency values, the generic drug maker said Thursday.

October 17, 2013

Generic drug maker Mylan has appointed Jacek Glinka as president of its European division, the company said Thursday.

PITTSBURGH — Generic drug maker Mylan has appointed Jacek Glinka as president of its European division, the company said Thursday.

Glinka's appointment becomes effective Dec. 2. Before joining Mylan, he was CEO of Polpharma Group from 2003 to 2006 and again from 2009 until this year, helping the company expand from a small, local company to a leading drug company in central and eastern Europe, the Caucasus and Central Asia. The company became a leader in the Polish market and doubled its sales to more than $1 billion between 2011 and 2013.

September 30, 2013

Mylan has launched the first generic version of a drug used to treat fungal infections, the company said Monday.

PITTSBURGH — Mylan has launched the first generic version of a drug used to treat fungal infections, the company said Monday.

The drug maker announced the launch of voriconazole for oral suspension in the 40-mg-per-mL strength. The drug is the first generic version of Pfizer's Vfend, and as the first company to receive approval for a generic version, Mylan has 180 days in which to compete exclusively against Pfizer's product. The drug is used to treat invasive fungal infections.

September 25, 2013

Mylan is challenging the patent protection on a drug used to treat fibromyalgia, prompting a lawsuit from the branded drug's manufacturers.

PITTSBURGH — Mylan is challenging the patent protection on a drug used to treat fibromyalgia, prompting a lawsuit from the branded drug's manufacturers.

Mylan said Wednesday that Forest Labs and Royalty Pharma had sued it in the U.S. District Court for the District of Delaware in connection with its filing of a regulatory approval application with the Food and Drug Administration for milnacipran hydrochloride tablets in the 12.5-mg, 25-mg, 50-mg and 100-mg strengths. The drug is a generic version of Savella.

September 10, 2013

Generic drugs have been on a roll with their share of total prescriptions dispensed in the country seeming to increase on a nearly constant basis. But it appears the peak is coming soon.

Generic drugs have been on a roll with their share of total prescriptions dispensed in the country seeming to increase on a nearly constant basis. But it appears the peak is coming soon.

(For the full category review, including sales data, click here.)

September 3, 2013

Indian regulators have approved a deal from Mylan to buy the injectables business of Strides Arcolab, Mylan said Tuesday.

PITTSBURGH — Indian regulators have approved a deal from Mylan to buy the injectables business of Strides Arcolab, Mylan said Tuesday.

Following the approval of Agila by India's Foreign Investment Promotion Board, Mylan also received approval from the Cabinet Committee on Economic Affairs. The deal is expected to close in fourth quarter 2013. Mylan announced its plan to buy Agila for $1.6 billion in February 2013.

August 22, 2013

The Food and Drug Administration has approved a supplemental regulatory application from Mylan for a generic antidepressant that was subject last year to scrutiny by the agency amid reports of efficacy problems, Mylan said Thursday.

PITTSBURGH — The Food and Drug Administration has approved a supplemental regulatory application from Mylan for a generic antidepressant that was subject last year to scrutiny by the agency amid reports of efficacy problems, Mylan said Thursday.

The drug maker announced the approval of its supplemental abbreviated new drug application, or sANDA, for bupropion hydrochloride extended-release tablets in the 300-mg strength. The drug is a generic version of GlaxoSmithKline's Wellbutrin XL.

August 19, 2013

The National Association of Chain Drug Stores has announced the winners of the 2013 NACDS Total Store Expo Product Showcase.

The 160 products, ranging from health and beauty to seasonal items, were on display in the “Product Showcase” on the exhibit floor.

ARLINGTON, Va. — The National Association of Chain Drug Stores has announced the winners of the 2013 NACDS Total Store Expo Product Showcase.  

The 160 products, ranging from health and beauty to seasonal items, were on display in the “Product Showcase” on the exhibit floor. The Showcase provided increased visibility for suppliers marketing products.  

August 14, 2013

In its first year, more than 20,000 schools across all 50 states participated in the program that offers four free EpiPen or EpiPen Jr (epinephrine) Auto-Injectors to qualifying schools in the United States.

BASKING RIDGE, N.J. — Mylan Specialty, the fully integrated specialty pharmaceutical business of Mylan, today announced a second year of its EpiPen4Schools program. In its first year, more than 20,000 schools across all 50 states participated in the program that offers four free EpiPen or EpiPen Jr (epinephrine) Auto-Injectors to qualifying schools in the United States. Qualifications include having a valid prescription.

August 8, 2013

Mike Aigner, director of national accounts, Mylan
Q: What do you hope to get out of the RBC show?
A: We'd like to reach as many customers as possible. Cardinal has been an absolutely great partner for many years.

August 6, 2013

Mylan's sales ticked up slightly in second quarter 2013, compared with the same period last year, the company said.

PITTSBURGH — Mylan's sales ticked up slightly in second quarter 2013, compared with the same period last year, the company said.

The Pittsburgh-based generic drug maker reported sales of $1.7 billion, a 1% increase over second quarter 2012's $1.69 billion. For the six-month period that ended June 30, sales were $3.33 billion, a 2% increase over $3.27 billion during the same period last year.

July 25, 2013

Mylan and Orion Corp. have settled a patent-infringement suit over a drug used to treat Parkinson's disease.

PITTSBURGH — Mylan and Orion Corp. have settled a patent-infringement suit over a drug used to treat Parkinson's disease, Mylan said Thursday.

The generic drug maker had filed with the Food and Drug Administration for a generic version of Orion's Stalevo (carpidopa; levodopa; entacapone) tablets, used to treat idiopathic Parkinson's to substitute for immediate-release carbidopa/levodopa and entacapone administered separately.

July 24, 2013

Mylan has settled with the makers of a drug used to treat cancer in a patent-infringement lawsuit, the generic drug maker said.

PITTSBURGH — Mylan has settled with the makers of a drug used to treat cancer in a patent-infringement lawsuit, the generic drug maker said Wednesday.

Mylan said it had entered an agreement with Pfizer, Genentech and OSI that would allow their suit against Mylan over the drug Tarceva (erlotinib) to be dismissed. All other terms and conditions of the settlement are confidential, and the agreement is subject to Department of Justice and Federal Trade Commission review, Mylan said.

July 23, 2013

A federal court has ruled that a Mylan lawsuit against GlaxoSmithKline over an antidepressant drug can go to trial.

PITTSBURGH — A federal court has ruled that a Mylan lawsuit against GlaxoSmithKline over an antidepressant drug can go to trial, Mylan said Tuesday.

Mylan alleges that GlaxoSmithKline breached a contract the two companies had made when it agreed to supply competing drug maker Apotex with paroxetine hydrochloride extended-release tablets, a generic version of Paxil CR. The Third Circuit Court of Appeals' ruling reversed a summary judgment dismissing Mylan's claim.

July 17, 2013

A federal court in New York has dismissed a lawsuit alleging that Mylan infringed four of Teva Pharmaceutical Industries' patents when it sought Food and Drug Administration approval for a multiple sclerosis drug.

PITTSBURGH — A federal court in New York has dismissed a lawsuit alleging that Mylan infringed four of Teva Pharmaceutical Industries' patents when it sought Food and Drug Administration approval for a multiple sclerosis drug.

Mylan had filed with the FDA for approval of a generic version of Teva's Copaxone (glatiramer acetate), attracting a patent-infringement suit from Teva alleging that it violated four patents on the drug, according to FDA records. The U.S. District Court for the Southern District of New York has dismissed the case.

July 16, 2013

Mylan has launched a generic contraceptive therapy, the drug maker said Tuesday.

PITTSBURGH — Mylan has launched a generic contraceptive therapy, the drug maker said Tuesday.

Mylan, through its Mylan Pharmaceuticals subsidiary, announced the launch of norethindrone tablets in the 0.35-mg strength. The drug is a generic version of Actavis' Nor-Q.D. tablets, which are taken on a 28-day cycle to prevent pregnancy. Mylan is partnering with Famy Care, which filed for and received Food and Drug Administration approval for the drug.

July 15, 2013

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

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

Mylan announced the launch of generic fenofibric acid delayed-release capsules in the 45-mg and 135-mg strengths.

The drug is a generic version of Abbott's Trilipix, designed for use in combination with statin drugs and diet to reduce triglycerides and increase high-density lipoprotein or "good" cholesterol.

Various versions of the drug had sales of about $553.6 million during the 12-month period that ended in March, according to IMS Health.

July 11, 2013

Mylan is challenging a patent on a drug used to treat ulcerative proctitis, the generic drug maker said Thursday.

PITTSBURGH — Mylan is challenging a patent on a drug used to treat ulcerative proctitis, the generic drug maker said Thursday.

Mylan said it had filed a regulatory approval application with the Food and Drug Administration for melamine rectal suppositories in the 1,000-mg strength. The drug is a generic version of Canasa, which had sales of about $153 million during the 12-month period that ended in March, according to IMS Health.

July 9, 2013

Mylan has received tentative approval for a generic version of a cholesterol drug made by AstraZeneca, according to Food and Drug Administration records.

SILVER SPRING, Md. — Mylan has received tentative approval for a generic version of a cholesterol drug made by AstraZeneca, according to Food and Drug Administration records.

The FDA gave the tentative approval to Mylan's rosuvastatin calcium tablets in the 5 mg, 10 mg, 20 mg and 40 mg strengths. The drug is a generic version of AstraZeneca's Crestor, which had sales of $5.1 billion in 2012, according to IMS Health.

July 8, 2013

A chronic obstructive pulmonary disease and asthma drug made by Sunovion infringes Mylan's patents on a similar drug, a federal judge has ruled, Mylan said.

PITTSBURGH – A chronic obstructive pulmonary disease and asthma drug made by Sunovion infringes Mylan's patents on a similar drug, a federal judge has ruled, Mylan said Monday.

The U.S. District Court for the Southern District of New York ruled that Sunovion's Brovana (arformoterol tartrate) infringes five patents related to Perforomist (formoterol fumarate), made by Mylan Specialty, the drug maker's branded products division.

June 26, 2013

Mylan has launched a generic version of a Johnson & Johnson contraceptive, the company said Wednesday.

PITTSBURGH — Mylan has launched a generic version of a Johnson & Johnson contraceptive, the company said Wednesday.

Mylan announced the launch of norethindrone tablets in the 0.35 mg strength. The drug is a generic version of Micronor, made by J&J subsidiary Janssen Pharmaceuticals. A company partnering with Mylan on the drug, Famy Care, received approval from the Food and Drug Administration for the drug.

Various versions of the drug had sales of about $57.2 million during the 12-month period that ended in March, according to IMS Health.