Content about Mylan

December 18, 2012

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

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

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

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


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


November 15, 2012

The Food and Drug Administration has approved a generic drug for leukemia made by a subsidiary of Par Pharmaceutical Cos.


FDA approves Par leukemia drug
WOODCLIFF LAKE, N.J. — The Food and Drug Administration has approved a generic drug for leukemia made by a subsidiary of Par Pharmaceutical Cos.


Par said Oct. 25 that the FDA had approved Anchen Pharmaceuticals’ tretinoin capsules in the 10-mg strength.


The drug is a generic version of Roche’s Vesanoid, various versions of which have annual sales of about $29 million, according to IMS Health.



 

November 13, 2012

Nearly 160 students, faculty and staff from Duquesne University’s Mylan School of Pharmacy recently visited Capitol Hill to promote the role that pharmacists play in providing medication therapy management services, the university announced Tuesday.

PITTSBURGH — Nearly 160 students, faculty and staff from Duquesne University’s Mylan School of Pharmacy recently visited Capitol Hill to promote the role that pharmacists play in providing medication therapy management services, the university announced Tuesday.

Student pharmacists from the School of Pharmacy’s class of 2015 met with members from 37 U.S. House and Senate offices on Oct. 22 to demonstrate how pharmacist-provided medication therapy management services can improve patient healthcare outcomes and reduce healthcare costs.

November 13, 2012

The Food and Drug Administration has approved a generic drug made by Mylan for treating pulmonary arterial hypertension, the drug maker said Tuesday.

PITTSBURGH — The Food and Drug Administration has approved a generic drug made by Mylan for treating pulmonary arterial hypertension, the drug maker said Tuesday.

Mylan announced the FDA approval of sildenafil citrate tablets in the 20-mg strength, a generic version of Pfizer's Revatio. The drug is used to treat adults with PAH to improve exercise ability and delay clinical worsening of the condition.

Revatio had sales of about $339 million during the 12-month period ended in September, according to IMS Health.

November 5, 2012

Whatever dazzling visions science fiction may offer of the widgets of the future, the long, uphill road of technology inevitably leads to the smaller and the simpler.

Whatever dazzling visions science fiction may offer of the widgets of the future, the long, uphill road of technology inevitably leads to the smaller and the simpler. The horse and carriage gave way to the automobile; vacuum tubes gave way to transistors; and computers that took up entire rooms and required intricate climate-control technologies now fit in one’s pocket. 


Technologies used in health care have undergone a similar transition, and much of that has happened in the last few years thanks to the spread of mobile technology. 


November 5, 2012

The Food and Drug Administration has approved a generic drug for treating blood pressure and chest pain.

FDA approves cardiovascular drug

MORRISTOWN, N.J. — The Food and Drug Administration has approved a generic drug for treating blood pressure and chest pain. Actavis announced the approval of diltiazem hydrochloride extended-release capsules.
The drug is a generic version of Valeant’s Tiazac. The branded drug and its generic equivalents had sales of about $76.3 million in 2011, according to IMS Health.



November 5, 2012

In what its president and CEO called a “significant milestone,” Watson Pharmaceuticals announced last month that the U.S. Federal Trade Commission and European Commission had approved its acquisition of Swiss generic drug maker Actavis.

In what its president and CEO called a “significant milestone,” Watson Pharmaceuticals announced last month that the U.S. Federal Trade Commission and European Commission had approved its acquisition of Swiss generic drug maker Actavis. Watson announced the $5.6 billion acquisition of Actavis in April, a deal that is expected to make Watson the third-largest generic drug maker in the world, after Teva Pharmaceutical Industries and Mylan.

October 29, 2012

The Food and Drug Administration has approved a Type 2 diabetes drug made by Watson Pharmaceuticals, the company said, following a federal court's order for the agency to approve the drug.

PARSIPPANY, N.J. – The Food and Drug Administration has approved a Type 2 diabetes drug made by Watson Pharmaceuticals, the company said, following a federal court's order for the agency to approve the drug.

Watson announced the launch of pioglitazone hydrochloride tablets in the 15-mg, 30-mg and 45-mg strengths. The drug is a generic version of Takeda's Actos, branded and generic versions of which had sales of about $2.7 billion during the 12-month period ended in August, according to IMS Health.

October 24, 2012

Mylan is challenging a federal court decision ordering the Food and Drug Administration to allow Watson Pharmaceuticals to launch a generic diabetes drug, Mylan said.

PITTSBURGH — Mylan is challenging a federal court decision ordering the Food and Drug Administration to allow Watson Pharmaceuticals to launch a generic diabetes drug, Mylan said.

The generic drug maker said it filed a motion in the U.S. District Court for the District of Columbia Tuesday to stay the court's order, which called on the FDA to let Watson launch a generic version of Takeda's Type 2 diabetes drug Actos (pioglitazone).

October 17, 2012

Generic drug maker Mylan and World TeamTennis announced a three-year agreement under which WTT will be renamed Mylan World TeamTennis.

PITTSBURGH — Generic drug maker Mylan and World TeamTennis announced a three-year agreement under which WTT will be renamed Mylan World TeamTennis.

October 10, 2012

Mylan has settled a patent infringement suit over a drug used to treat respiratory diseases, Mylan said.

PITTSBURGH — Mylan has settled a patent infringement suit over a drug used to treat respiratory diseases, Mylan said.

The generic drug maker said it resolved a patent litigation suit filed by Shionogi and Cima Labs over prednisolone sodium phosphate orally disintegrating tablets, a generic version of Orapred ODT. Mylan is hoping to market its generic version of the drug in the 10-mg, 15-mg and 30-mg strengths. The drug is used to treat asthma and certain allergic conditions.

September 28, 2012

Generic drug maker Mylan has received regulatory approval for a drug used to treat high blood pressure, also known as hypertension, the company said Friday.

PITTSBURGH — Generic drug maker Mylan has received regulatory approval for a drug used to treat high blood pressure, also known as hypertension, the company said Friday, saying that it would launch both drugs immediately.

Mylan said the Food and Drug Administration approved its irbesartan tablets in the 75 mg, 150 mg and 300 mg strengths and irbesartan and hydrochlorothiazide tablets in the 150 mg/12.5 mg and 300 mg/12.5 mg strengths. The drugs are respectively generic versions of Sanofi's Avapro and Avalide.

September 26, 2012

Mylan Specialty has hired a star of a popular TV series as a celebrity spokeswoman for a campaign designed to draw attention to severe allergic reactions.

BASKING RIDGE, N.J. — Mylan Specialty has hired a star of a popular TV series as a celebrity spokeswoman for a campaign designed to draw attention to severe allergic reactions.

September 21, 2012

The Food and Drug Administration has approved a blood pressure medication made by Mylan.

PITTSBURGH — The Food and Drug Administration has approved a blood pressure medication made by Mylan.

The drug maker announced Friday the approval of valsartan and hydrochlorothiazide tablets in the 80-mg/12.5-mg, 160-mg/12.5-mg, 160-mg/25-mg, 320-mg/12.5-mg and 320-mg/25-mg strengths.

The drug, a generic version of Novartis' Diovan HCT, is used to treat high blood pressure, or hypertension, in patients who can't control their blood pressure with one drug or who are starting therapy and need multiple drugs.

September 21, 2012

The Food and Drug Administration has approved a generic drug for motion sickness made by Mylan.

PITTSBURGH — The Food and Drug Administration has approved a generic drug for motion sickness made by Mylan.

The drug maker announced Friday that the FDA had approved meclizine hydrochloride tablets in the 12.5-mg, 25-mg and 50-mg strengths. Mylan said it would launch the drug immediately.

The drug is a generic version of Pfizer's Antivert, which is used to treat nausea, vomiting and dizziness associated with motion sickness. Antivert had sales of about $53.5 million during the 12-month period ended in June, according to IMS Health.

September 18, 2012

Over the last few years of DSN’s coverage of the impending patent cliff and how it would affect the generic drug industry, IMS Health VP industry relations Doug Long predicted that the gradual commoditization of primary care drugs — long the lifeblood of generic drug makers — would lead to consolidation of the industry.


Over the last few years of DSN’s coverage of the impending patent cliff and how it would affect the generic drug industry, IMS Health VP industry relations Doug Long predicted that the gradual commoditization of primary care drugs — long the lifeblood of generic drug makers — would lead to consolidation of the industry.


September 18, 2012

Generic drug makers Hospira, Sagent Pharmaceuticals and Teva Pharmaceutical Industries have launched generic versions of a chemotherapy drug made by Sanofi, the three companies said last month.


NEW YORK — Generic drug makers Hospira, Sagent Pharmaceuticals and Teva Pharmaceutical Industries have launched generic versions of a chemotherapy drug made by Sanofi, the three companies said last month.


September 18, 2012

For branded drug makers, the pharmaceutical patent cliff has never loomed higher or steeper. The exposure of so many of the world’s biggest-selling medicines to generic competition for the first time is redefining the pricing model for many of the most widely prescribed classes of pharmaceuticals.

For branded drug makers, the pharmaceutical patent cliff has never loomed higher or steeper. The exposure of so many of the world’s biggest-selling medicines to generic competition for the first time is redefining the pricing model for many of the most widely prescribed classes of pharmaceuticals — reducing costs for health plans, payers and patients; scrambling drug makers’ balance sheets; and potentially boosting both drug utilization and adherence rates as reduced out-of-pocket costs induce more patients to fill their prescriptions.


September 7, 2012

Generic drug maker Mylan has settled a patent litigation suit with Pfizer concerning a drug for treating bladder disorders, Mylan said Friday.

PITTSBURGH — Generic drug maker Mylan has settled a patent litigation suit with Pfizer concerning a drug for treating bladder disorders, Mylan said Friday.

The Pittsburgh-based company said it settled with Pfizer over its generic version of Detrol LA (tolterodine tartrate) extended-release capsules in the 2-mg and 4-mg strengths. The drug is used to treat urge urinary incontinence, urgency and frequency.

September 6, 2012

Mylan has launched an application version of the reference guide to its drugs, the generic drug maker said Thursday.

PITTSBURGH — Mylan has launched an application version of the reference guide to its drugs, the generic drug maker said Thursday.

The company announced what it called the first ever app of its Generic Brand Reference Guide, a free reference for healthcare professionals, patients and pharmacy students that enables the fast identification of brand and generic drugs. The 2012 print edition of the GBR was made available in a pocket-sized format earlier this year.

August 27, 2012

The Food and Drug Administration has approved the first generic version of a diabetes drug made by Takeda, the agency said Friday.

SILVER SPRING, Md. — The Food and Drug Administration has approved the first generic version of a diabetes drug made by Takeda, the agency said Friday.

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.