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April 18, 2014

Merck on Thursday announced that the Food and Drug Administration has approved Ragwitek (short ragweed pollen allergen extract) tablet for sublingual use (12 Amb a 1-U).

WHITEHOUSE STATION, N.J. — Merck on Thursday announced that the Food and Drug Administration has approved Ragwitek (short ragweed pollen allergen extract) tablet for sublingual use (12 Amb a 1-U). Ragwitek is an allergen extract indicated as immunotherapy for the treatment of short ragweed pollen-induced allergic rhinitis with or without conjunctivitis. Ragwitek is approved for use in adults ages 18 years through 65 years. 

April 15, 2014

Merck announced that the Food and Drug Administration has approved Grastek (Timothy grass pollen allergen extract) tablet for sublingual use.

WHITEHOUSE STATION, N.J. — Merck announced that the Food and Drug Administration has approved Grastek (Timothy grass pollen allergen extract) tablet for sublingual use. The drug is an allergen extract used for the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis. It is approved for use in persons ages 5 years through 65 years of age.

January 16, 2014

Merck on Wednesday commended the U.S. Food and Drug Administration’s Cardiovascular and Renal Drugs Advisory Committee’s recommendation for approval of vorapaxar.

WHITEHOUSE STATION, N.J. — Merck on Wednesday commended the U.S. Food and Drug Administration’s Cardiovascular and Renal Drugs Advisory Committee’s recommendation for approval of vorapaxar. Vorapaxar is the company’s investigational antiplatelet medicine for the reduction of atherothrombotic events, when added to standard of care, in patients with a history of heart attack and no history of stroke or transient ischemic attack.

January 13, 2014

Merck on Monday reported on its intent to explore strategic options for its animal health and consumer care businesses.

WHITEHOUSE STATION, N.J. — Merck on Monday reported on its intent to explore strategic options for its animal health and consumer care businesses. The company expects to complete the process and take action, if any, in 2014. 

Exploring strategic options for its animal health and consumer care businesses to determine the most value-creating option for each and could reach different decisions about the two businesses, Merck stated. 

January 10, 2014

The Food and Drug Administraiton has approved a liquid formulation of an HIV drug made by Merck, the company said.

WHITEHOUSE STATION, N.J. — The Food and Drug Administraiton has approved a liquid formulation of an HIV drug made by Merck, the company said.

Merck announced the approval of Isentress (raltegravir) for oral suspension, aimed at small children with HIV. The drug may be used by patients as young as four weeks, and the full line of formulations of Isentress now includes the orlal suspension, as well as chewable tablets and film--coated tablets. The company plans to launch the oral suspension in the third quarter of this year.

December 30, 2013

Drug maker Merck is starting a new business designed to provide weight-management intervention services to employers, patients and healthcare professionals, the company said.

WHITEHOUSE STATION, N.J. — Drug maker Merck is starting a new business designed to provide weight-management intervention services to employers, patients and healthcare professionals, the company said.

November 26, 2013

The Food and Drug Administration has approved a new tablet form of an antifungal drug made by Merck, the company said Tuesday.

WHITEHOUSE STATION, N.J. — The Food and Drug Administration has approved a new tablet form of an antifungal drug made by Merck, the company said Tuesday.

Merck announced the FDA approval of Noxafil (posaconazole) 100-mg delayed release tablets. The company also markets a 40-mg-per-milliliter oral suspension form of the drug. The new tablet formulation is designed to be taken in two 300-mg doses on the first day, followed by a 300-mg dose once per day.

October 24, 2013

The Food and Drug Administration has granted breakthrough therapy designation to an experimental drug made by Merck for hepatitis C, the drug maker said.

WHITEHOUSE STATION, N.J. — The Food and Drug Administration has granted breakthrough therapy designation to an experimental drug made by Merck for hepatitis C, the drug maker said.

October 9, 2013

Flu is at the top of the list of diseases older adults plan to ask about, according to results from a new Harris Interactive consumer awareness survey, sponsored by Merck. Most of the more than 600 surveyed adults age 60 years and older are at least somewhat likely to ask their healthcare professional about preventing the flu this year, and are significantly more likely to ask about this than prevention of such other potentially serious diseases as shingles.

WHITEHOUSE STATION, N.J. — Flu is at the top of the list of diseases older adults plan to ask about, according to results from a new Harris Interactive consumer awareness survey, sponsored by Merck. Most of the more than 600 surveyed adults age 60 years and older are at least somewhat likely to ask their healthcare professional about preventing the flu this year, and are significantly more likely to ask about this than prevention of such other potentially serious diseases as shingles.

September 26, 2013

Merck Consumer Care announced that Oxytrol for Women is now on shelf for the more than 20 million women suffering from overactive bladder.

WHITEHOUSE STATION, N.J. — Merck Consumer Care on Wednesday announced that Oxytrol for Women is now on shelf for the more than 20 million women suffering from overactive bladder. Oxytrol for Women is a thin, flexible patch that is discreetly applied to the abdomen, hip or buttock once every four days for the relief of overactive bladder in women. It is the first and only over-the-counter option that treats the OAB symptoms — urinary incontinence, urgency and frequency — which can take a physical and emotional toll on women.

July 1, 2013

The Food and Drug Administration has declined to approve a sleeping pill made by Merck & Co., citing issues with dosage.

WHITEHOUSE STATION, N.J. — The Food and Drug Administration has declined to approve a sleeping pill made by Merck & Co., citing issues with dosage.

The drug maker said Monday that it received a complete response letter from the FDA concerning the drug suvorexant, for which it is seeking regulatory approval. A complete response letter means that the agency has finished reviewing its approval application, but questions remain that preclude final approval.

May 16, 2013

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

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

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 8, 2013

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.

January 25, 2013

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. 

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 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.

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.

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 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).

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 7, 2012

A drug under development by Merck "significantly" reduced the risk of heart attack, stroke and cardiovascular death in patients, according to clinical trial results announced Tuesday.

WHITEHOUSE STATION, N.J. — A drug under development by Merck "significantly" reduced the risk of heart attack, stroke and cardiovascular death in patients, according to clinical trial results announced Tuesday.

February 2, 2012

The Food and Drug Administration has approved a drug made by Merck for Type 2 diabetes, the drug maker said Thursday.

WHITEHOUSE STATION, N.J. — The Food and Drug Administration has approved a drug made by Merck for Type 2 diabetes, the drug maker said Thursday.

Merck announced the approval of Janumet XR (sitagliptin and metformin hydrochloride) extended-release tablets as a once-daily treatment for the disease.

October 6, 2011

Merck chairman Richard Clark is retiring, the company said Thursday.

WHITEHOUSE STATION, N.J. — Merck chairman Richard Clark is retiring, the company said Thursday.

Merck announced that Clark, who remained chairman of the company after stepping down as president and CEO in 2010, would retire from the company and its board of directors as of Dec. 1. Kenneth Frazier took over as president and CEO in January 2011, and the board has elected him to serve as chairman following Clark's departure.