Content about Merck

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.

January 2, 2013

Wall Street on Wednesday celebrated the "fiscal cliff" compromise as stocks across the board were trading up by some 200 basis points. As of noon, the Dow was up 1.7% and Nasdaq 2.3%.

NEW YORK — Wall Street on Wednesday celebrated the "fiscal cliff" compromise as stocks across the board were trading up by some 200 basis points. As of noon, the Dow was up 1.7% and Nasdaq 2.3%. 

December 18, 2012

A majority of prescribers would prescribe biosimilar versions of two treatments for rheumatoid arthritis within a year of their approval, according to a new study.

BURLINGTON, Mass. — A majority of prescribers would prescribe biosimilar versions of two treatments for rheumatoid arthritis within a year of their approval, according to a new study.

December 3, 2012

Merck has started a clinical trial that it hopes will eventually enroll 1,700 patients to evaluate an experimental drug for Alzheimer's disease, the company said.

WHITEHOUSE STATION, N.J. — Merck has started a clinical trial that it hopes will eventually enroll 1,700 patients to evaluate an experimental drug for Alzheimer's disease, the company said.

Merck announced the start of "EPOCH," a combined phase-2 and phase-3 study of the drug MK-8931, a 78-week trial in which patients will take either the drug in the 12-mg, 40-mg or 60-mg doses or placebo.

November 15, 2012

The Food and Drug Administration's Nonprescription Drugs Advisory Committee on Friday voted against Merck's application to switch its Oxytrol patch from prescription-only to over the counter, citing concerns over use of therapy for an overactive bladder in women without a doctor's intervention.

SILVER SPRING, Md. — The Food and Drug Administration's Nonprescription Drugs Advisory Committee on Friday voted against Merck's application to switch its Oxytrol patch from prescription-only to over the counter, citing concerns over use of therapy for an overactive bladder in women without a doctor's intervention. 

The committee voted five in favor and six opposed, also citing concerns that men might inappropriately choose to use the product as well. 

November 8, 2012

The Food and Drug Administration has accepted an application from Merck for an experimental drug for insomnia, the drug maker said Thursday.

WHITEHOUSE STATION, N.J. — The Food and Drug Administration has accepted an application from Merck for an experimental drug for insomnia, the drug maker said Thursday.

Merck announced the the FDA's acceptance of its regulatory filing for suvorexant, which the FDA's Controlled Substances Staff will review while the agency is reviewing the application.

October 16, 2012

Perrigo has received tentative approval from the U.S. Food and Drug Administration for its abbreviated new drug application to market over-the-counter omeprazole and sodium bicarbonate capsules in the 20-mg/1,100-mg strength, the store-brand equivalent to Merck's Zegerid OTC.

ALLEGAN, Mich. — Perrigo has received tentative approval from the U.S. Food and Drug Administration for its abbreviated new drug application to market over-the-counter omeprazole and sodium bicarbonate capsules in the 20-mg/1,100-mg strength, the store-brand equivalent to Merck's Zegerid OTC.

Zegerid OTC (omeprazole and sodium bicarbonate capsules 20 mg/1,100 mg), a proton-pump inhibitor indicated to relieve frequent heartburn, had sales of approximately $42 million through food, drug and mass merchandisers for the lastest 12 months.

October 11, 2012

A German drug maker is pledging millions of dollars for multiple sclerosis research, the company's U.S. subsidiary said Thursday.

ROCKLAND, Mass. — A German drug maker is pledging millions of dollars for multiple sclerosis research, the company's U.S. subsidiary said Thursday.

October 9, 2012

Merck is moving its global headquarters from Whitehouse Station, N.J., to its existing property in Summit, N.J., which currently houses research, manufacturing, animal health and consumer care operations.

WHITEHOUSE STATION, N.J. — Merck is moving its global headquarters from Whitehouse Station, N.J., to its existing property in Summit, N.J., which currently houses research, manufacturing, animal health and consumer care operations.

September 27, 2012

Dr. Reddy's Labs has launched a generic drug for treating asthma and allergies, and preventing bronchospasm during exercise, the company said.

HYDERABAD, India — Dr. Reddy's Labs has launched a generic drug for treating asthma and allergies, and preventing bronchospasm during exercise, the company said.

The Indian company announced the launch of montelukast sodium oral granules in the 4-mg strength in unit-dose cartons of 30 packets.

The drug is a version of Merck's Singulair oral granules, which had sales of about $61 million during the 12-month period ended in July, according to IMS Health.

September 20, 2012

Atlanta-based reproductive and sexual health organization SisterLove and drug maker Merck have collaborated to create a mini-documentary and educational HIV/AIDS treatment and care resource.

ATLANTA — Atlanta-based reproductive and sexual health organization SisterLove and drug maker Merck have collaborated to create a mini-documentary and educational HIV/AIDS treatment and care resource.

September 10, 2012

A study of an experimental drug for insomnia indicated that patients who stop taking it continue having sleeping problems, according to results of a clinical trial announced Monday.

WHITEHOUSE STATION, N.J. — A study of an experimental drug for insomnia indicated that patients who stop taking it continue having sleeping problems, according to results of a clinical trial announced Monday.

Merck released data from a phase-3 trial of suvorexant in which patients who had been taking the drug daily for a year were switched to placebo for a two-month "discontinuation phase." Patients who were switched from the drug to placebo showed sleeping difficulties similar to those who had consistently taken placebo.

June 21, 2012

It’s been cited as one of the biggest health crises facing the United States and, if solved, the equivalent dollar value of a blockbuster drug. According to the latest statistics from pharmacy benefit manager Express Scripts, poor medication adherence costs the country $317 billion per year, an upgrade from the $290 billion calculated in a study released in 2009 by the New England Healthcare Institute.


It’s been cited as one of the biggest health crises facing the United States and, if solved, the equivalent dollar value of a blockbuster drug. According to the latest statistics from pharmacy benefit manager Express Scripts, poor medication adherence costs the country $317 billion per year, an upgrade from the $290 billion calculated in a study released in 2009 by the New England Healthcare Institute.


June 18, 2012

Merck announced that the U.S. District Court for the District of New Jersey ruled against the company in a patent infringement suit against Canada-based drug maker Apotex.

WHITEHOUSE STATION, N.J. — Merck announced that the U.S. District Court for the District of New Jersey ruled against the company in a patent infringement suit against Canada-based drug maker Apotex.

June 13, 2012

Merck on Wednesday released new data from two pivotal Phase III efficacy trials for suvorexant, the investigational medicine Merck is developing for the treatment of insomnia.

BOSTON — Merck on Wednesday released new data from two pivotal Phase III efficacy trials for suvorexant, the investigational medicine Merck is developing for the treatment of insomnia.

Merck expects to file a new drug application to the Food and Drug Administration in 2012. If approved, suvorexant would be the first medicine approved in a new class of medicines, called orexin receptor antagonists, for use in patients with difficulty falling or staying asleep. Merck anticipates that suvorexant will be evaluated by the Controlled Substance Staff of the FDA.

May 1, 2012

The philanthropic arm of the American Pharmacists Association has announced this year's recipients of an award that recognizes pharmacists who increase medication adherence, reduce drug misadventures and promote the use of national treatment guidelines.

WASHINGTON — The philanthropic arm of the American Pharmacists Association has announced this year's recipients of an award that recognizes pharmacists who increase medication adherence, reduce drug misadventures and promote the use of national treatment guidelines.

April 30, 2012

Mylan will be barred from marketing a generic version of a Merck cardiovascular drug until the drug's patent expires, under a court ruling announced Friday.

WHITEHOUSE STATION, N.J. — Mylan will be barred from marketing a generic version of a Merck cardiovascular drug until the drug's patent expires, under a court ruling announced Friday.

Merck said the U.S. District Court for the District of New Jersey ruled against Mylan in two patent infringement suits related to the drugs Zetia (ezetimibe) and Vytorin (ezetimibe and simvastatin). Specifically, the court ruled that a patent covering the drug, RE 42,461, is valid and enforceable and enjoined Mylan from launching until the patents expiration in April 2017.

April 20, 2012

Merck is testing two means of treating patients with chronic hepatitis C for anemia, a common side effect of certain treatments for the viral infection, the drug maker said.

BARCELONA, Spain — Merck is testing two means of treating patients with chronic hepatitis C for anemia, a common side effect of certain treatments for the viral infection, the drug maker said.

Merck announced results of a phase-3 study comparing two strategies for managing anemia and how they affect the curing of hepatitis C in patients taking Victrelis (boceprevir) with Pegintron (peginterferon alfa-2b) and ribavirin.

April 16, 2012

Two drug makers have signed a deal to develop an experimental drug for treating two types of cancer.

WHITEHOUSE STATION, N.J. — Two drug makers have signed a deal to develop an experimental drug for treating two types of cancer.

Merck and Endocyte announced that they would develop and commercialize the latter's drug EC145 (vintafolide), currently in a phase-3 trial, as a treatment for platinum-resistant ovarian cancer and a phase-2 trial for non-small cell lung cancer. Both studies are also using Endocyte's experimental diagnostic agent, EC20 (etarfolatide).

April 9, 2012

The Food and Drug Administration has approved a change to the label of a Novo Nordisk drug stating that it offers superior blood-sugar control to a competing drug made by Merck, based on results of two clinical studies, Novo Nordisk said Monday.

PRINCETON, N.J. — The Food and Drug Administration has approved a change to the label of a Novo Nordisk drug stating that it offers superior blood-sugar control to a competing drug made by Merck, based on results of two clinical studies, Novo Nordisk said Monday.

April 3, 2012

Drug maker Merck has introduced a new program that's designed to provide resources and information to help patients with Type 2 diabetes commit to living a diabetes-friendly lifestyle.

WHITEHOUSE STATION, N.J. — Drug maker Merck has introduced a new program that's designed to provide resources and information to help patients with Type 2 diabetes commit to living a diabetes-friendly lifestyle.

March 22, 2012

GlaxoSmithKline on Thursday morning presented exactly how technology might improve appropriate patient self-selection before a panel convened by the Food and Drug Administration to explore expanding the prescripton-to-over-the-counter switch paradigm by incorporating technology and/or pharmacy participation in the application process.

SILVER SPRING, Md. — GlaxoSmithKline on Thursday morning presented exactly how technology might improve appropriate patient self-selection before a panel convened by the Food and Drug Administration to explore expanding the prescripton-to-over-the-counter switch paradigm by incorporating technology and/or pharmacy participation in the application process.

March 6, 2012

The Food and Drug Administration is asking for additional data before it approves a new cholesterol drug made by Merck, the drug maker said.

WHITEHOUSE STATION, N.J. — The Food and Drug Administration is asking for additional data before it approves a new cholesterol drug made by Merck, the drug maker said.

Merck said the agency issued a complete response letter for its regulatory approval application for a drug that would combine the cholesterol drug Zetia (ezetimibe) with atorvastatin, the active ingredient in Pfizer's Lipitor. A complete response letter means that the FDA cannot approve a drug application in its current form.

February 17, 2012

The Food and Drug Administration has approved a drug made by Merck for Type 2 diabetes, the drug maker said. Merck announced the approval of Janumet XR (sitagliptin and metformin hydrochloride) extended-release tablets as a once-daily treatment for the disease.


SUPPLIER NEWS — The Food and Drug Administration has approved a drug made by Merck for Type 2 diabetes, the drug maker said. Merck announced the approval of Janumet XR (sitagliptin and metformin hydrochloride) extended-release tablets as a once-daily treatment for the disease.


February 14, 2012

Perrigo on Tuesday announced that it has begun shipping Loratadine-D 12-hour extended-release tablets.

ALLEGAN, Mich. — Perrigo on Tuesday announced that it has begun shipping Loratadine-D 12-hour extended-release tablets.