Content about Merck

June 4, 2013

AmeriCares honors Merck with Power of Partnership Award

AmeriCares on Monday presented its annual Power of Partnership Award to Merck in recognition of the company’s commitment to helping disaster survivors and improving health in the developing world.

STAMFORD, Conn. — AmeriCares on Monday presented its annual Power of Partnership Award to Merck in recognition of the company’s commitment to helping disaster survivors and improving health in the developing world. Merck is one of AmeriCares most committed donors, providing both products and financial support for the global health and disaster relief organization’s aid programs, the organization stated.

May 30, 2013

Liability of harmful side effects questioned

This summer, the Supreme Court will decide on a case that could determine whether generic drug makers can be held liable when patients suffer harmful side effects from taking their drugs.

May 30, 2013

States consider 'carve-out'-style laws for biosimilars

While the passage of the Patient Protection and Affordable Care Act of 2010 was a milestone in a number of respects, it also was one of the biggest moments in the history of the generic drug industry since the 1984 passage of the Hatch-Waxman Act, which created an abbreviated regulatory approval pathway for generic pharmaceutical drugs.

May 16, 2013

Coppertone encourages parents to protect children from UV rays year-round

Merck Consumer Care, the makers of Coppertone, launched today the "Making the Sunscreen Grade" program to equip parents with tools to help their children develop lifelong sun habits.

WHITEHOUSE STATION, N.J. — Merck Consumer Care, the makers of Coppertone, launched today the "Making the Sunscreen Grade" program to equip parents with tools to help their children develop lifelong sun habits, including those that protect them from the sun during the school day.

May 8, 2013

Merck submits FDA filing for ragweed allergy drug

Drug maker Merck is seeking regulatory approval for an experimental tablet placed under the tongue that could be used to treat ragweed allergies.

WHITEHOUSE STATION, N.J. — Drug maker Merck is seeking regulatory approval for an experimental tablet placed under the tongue that could be used to treat ragweed allergies.

Merck said the Food and Drug Administration accepted a regulatory application for its ragweed pollen sublingual allergy immunotherapy tablet. Ragweed, also known as Ambrosia artemisiifolia, is a major cause of seasonal allergies in the United States. Merck also submitted an application for a similar drug, for Timothy grass pollen allergies, in March.

May 6, 2013

FDA approves Merck cholesterol drug

The Food and Drug Administration has approved a new drug made by Merck for treating high cholesterol, the drug maker said.

WHITEHOUSE STATION, N.J. — The Food and Drug Administration has approved a new drug made by Merck for treating high cholesterol, the drug maker said.

Merck announced the approval of Liptruzet (ezetimibe and atorvastatin). The drug combines two preexisting cholesterol drugs: ezetimibe, which Merck markets under the brand name Zetia, and atorvastatin, which Pfizer markets under the name Lipitor. Both drugs are available as generics, but because Liptruzet is a novel combination of them, it required FDA approval as a new drug.

March 19, 2013

Supreme Court to hear generic drug liability case

The question of whether a generic drug company can be held liable for harmful side effects from its medicines goes before the Supreme Court Tuesday in a case involving a New Hampshire woman who sustained several injuries after taking a generic pain drug.

WASHINGTON — The question of whether a generic drug company can be held liable for harmful side effects from its medicines goes before the Supreme Court Tuesday in a case involving a New Hampshire woman who sustained several injuries after taking a generic pain drug.

March 14, 2013

Merck's James Mackey elected CHPA chairman

The Consumer Healthcare Products Association officially elected James Mackey, SVP U.S. region head for Merck Consumer Care, as the association's chairman.

NAPLES, Fla. — The Consumer Healthcare Products Association on Wednesday officially elected James Mackey, SVP U.S. region head for Merck Consumer Care, as the association's chairman. Paul Sturman, president and general manager Pfizer Consumer Healthcare, will serve as immediate past chairman.

March 8, 2013

Leticia Moreinos Schwartz to promote Type 2 diabetes awareness among Hispanics

Drug maker Merck has hired celebrity chef and cookbook author Leticia Moreinos Schwartz as a spokeswoman to reach out to Hispanics living with Type 2 diabetes, the drug maker said.

WHITEHOUSE STATION, N.J. — Drug maker Merck has hired celebrity chef and cookbook author Leticia Moreinos Schwartz as a spokeswoman to reach out to Hispanics living with Type 2 diabetes, the drug maker said Friday.

February 26, 2013

Bausch + Lomb names new president, CFO

Bausch + Lomb named Robert Bertolini as president and CFO effective immediately.

ROCHESTER, N.Y. — Bausch + Lomb on Tuesday named Robert Bertolini as president and CFO effective immediately. In this capacity, he will oversee the company's finance, information technology and global quality and operations functions. Bertolini, who assumes CFO responsibilities from Brian Harris, will report to Bausch + Lomb CEO Brent Saunders.

February 8, 2013

Rx-to-OTC switches could be boon as FDA looks at switch paradigm

A new report by Francesco International identified $35.7 billion worth of potential Rx-to-OTC switches in a wide range of indications, from hypertension and chronic obstructive pulmonary disorder to high cholesterol and erectile dysfunction, and the Food and Drug Administration has been looking at ways technology and pharmacists could be employed to ensure that patients taking drugs new to the consumer health space take them appropriately.

With growth in traditional pharmaceuticals expected to slow down significantly, a growing number of drug makers — branded and generic alike — see specialty drugs as their main sources of revenue for the foreseeable future. At the same time, those drug makers not invested in specialty may be looking for growth opportunities in consumer health.

January 25, 2013

Merck: FDA approves Oxytrol for Women, creating overactive bladder category in OTC

Merck on Friday announced the Food and Drug Administration has approved the switch of Oxytrol for Women (oxybutynin transdermal system, 3.9 mg/day) from prescription-only to nonprescription, creating a new category — overactive bladder in women — in the OTC area.

WHITEHOUSE STATION, N.J. — Merck on Friday announced the Food and Drug Administration has approved the switch of Oxytrol for Women (oxybutynin transdermal system, 3.9 mg/day) from prescription-only to nonprescription, creating a new category — overactive bladder in women — in the OTC area. Most notable about this switch is the fact that the FDA approved Oxytrol for Women against the majority opinion of its Nonprescription Drug Advisory Committee, which voted five in favor and six opposed to the switch in November.

January 4, 2013

FDA approves new delivery method for MS drug

The Food and Drug Administration has approved a new means of administration for a multiple sclerosis drug, the manufacturers said.

NEW YORK — The Food and Drug Administration has approved a new means of administration for a multiple sclerosis drug, the manufacturers said.

Pfizer and EMD Serono announced the approval of Rebif Rebidose (interferon beta-1a), a single-use auto-injector for self-administering Rebif, used to treat relapsing forms of MS. EMD Serono is the U.S. division of German drug maker Merck KGaA, so-named to avoid confusion with U.S.-based Merck & Co.

January 3, 2013

Dr. Reddy's launches hair-loss drug

Dr. Reddy's Labs has launched a generic drug for treating baldness, the Indian drug maker said.

HYDERABAD, India — Dr. Reddy's Labs has launched a generic drug for treating baldness, the Indian drug maker said.

Dr. Reddy's announced the launch of finasteride tablets in the 1-mg strength, a generic version of Merck's Propecia. As the first company to successfully file for approval of a generic version of the drug, Dr. Reddy's is entitled to 180 days of market exclusivity in which to compete directly with the branded version.

Propecia had sales of about $136 million during the 12-month period that ended in October 2012, according to IMS Health.

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.

January 2, 2013

Stock market rebounds following 'fiscal cliff' compromise

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

Most prescribers would pick biosimilar RA drugs

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 starts Alzheimer's drug trial

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

FDA panel advises against Merck's Oxytrol patch Rx-to-OTC switch application

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

FDA accepts Merck application for insomnia drug

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 wins tentative approval for generic Zegerid OTC

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

Merck KGaA to donate $1.3 million per year to academic MS research

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 to move HQ in New Jersey

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 launches generic asthma, allergy, bronchospasm drug

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

Educational series from SisterLove, Merck shows 'everyone has a story'

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.