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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.

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. 

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.

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.

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.

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.

WHITEHOUSE STATION, N.J. — The Food and Drug Administration has accepted a regulatory approval application from Merck and Ariad Pharmaceuticals for a new drug to treat soft-tissue and bone cancers, the drug makers said Wednesday.

The FDA is expected to complete its review of ridaforolimus for soft-tissue and bone sarcomas in patients who have shown a favorable response to chemotherapy by second quarter 2012.

Sarcomas are cancers of the body's connective tissues, and treatment options remain limited, the companies said.

WHITEHOUSE STATION, N.J. — A team comprised of scientists from drug maker Merck and several U.S. universities will look for ways to eradicate HIV, Merck said.

WHITEHOUSE STATION, N.J. — Drug maker Merck has completed its acquisition of eye care company Inspire.

As previously reported, Merck announced its plan to acquire the company for $5 per share in cash, or $430 million. In addition, Monarch Transaction, a wholly-owned subsidiary of Merck, has merged with and into Inspire, with Inspire surviving as a wholly owned subsidiary of Merck, effective today.

WHITEHOUSE STATION, N.J. — Merck has cleared a hurdle in its effort to buy eye care company Inspire Pharmaceuticals for $430 million, the company said Thursday.

The expiration of the waiting period mandated by the Hart-Scott-Rodino Antitrust Improvements Act of 1976 brings Merck one step closer to acquiring Inspire.

Merck announced its intention to buy Raleigh, N.C.-based Inspire for $5 per share on April 15.

WHITEHOUSE STATION, N.J. — The Food and Drug Administration has approved a treatment made by Merck for treating skin cancer, Merck said Monday.

Merck announced the approval of Sylatron (peginterferon alfa-2b) as an add-on treatment for treating melanoma with microscopic of gross nodal involvement within 84 days of surgery.