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January 14, 2011

The Food and Drug Administration has approved a new formulation of a drug for treating acetaminophen poisoning.

NASHVILLE, Tenn. — The Food and Drug Administration has approved a new formulation of a drug for treating acetaminophen poisoning.

Cumberland Pharmaceuticals announced Thursday that the agency had approved a version of Acetadote (acetylcysteine) injection that does not contain preservatives or stabilization and chelating agents, and will replace the currently marketed version. The drug originally was approved in 2004.

January 4, 2011

The Food and Drug Administration has approved a topical testosterone replacement therapy made by Endo Pharmaceuticals, Endo said last week.

CHADDS FORD, Pa. — The Food and Drug Administration has approved a topical testosterone replacement therapy made by Endo Pharmaceuticals, Endo said last week.

The drug maker announced on Dec. 29 the approval of Fortesta (testosterone) gel, a treatment for men with low testosterone, which affects nearly 14 million men in the United States.

Endo said it planned to introduce Fortesta in the United States early this year.

November 30, 2010

A generic version of a drug indicated to treat attention deficit hyperactivity disorder has hit a roadblock.

HAYWARD, Calif. — A generic version of a drug indicated to treat attention deficit hyperactivity disorder has hit a roadblock.

November 14, 2010

The Food and Drug Administration has approved an attention deficit hyperactivity disorder drug for use...

PHILADELPHIA — The Food and Drug Administration has approved an attention deficit hyperactivity disorder drug for use in adolescents.

British drug maker Shire announced Monday the approval of Vyvanse (lisdexamfetamine dimesylate) capsules for patients aged 13 to 17. The drug was already approved for children ages 6 years to 12 years and adults.

November 8, 2010

Drug maker Upsher-Smith Labs will add an extension study to its late-stage clinical trial of...

MAPLE GROVE, Minn. Drug maker Upsher-Smith Labs will add an extension study to its late-stage clinical trial of a drug for treating epilepsy, the company said Tuesday.

 

Upsher-Smith announced an additional study for patients who completed the phase-3 “Prevail” trial of the drug USL255 (topiramate extended-release). The drug is designed to provide a once-daily dosage for adults with the disease.

 

 

November 1, 2010

Generic drug maker Watson Pharmaceuticals will distribute an authorized generic version of a drug used...

MORRISTOWN, N.J. Generic drug maker Watson Pharmaceuticals will distribute an authorized generic version of a drug used to treat attention deficit hyperactivity disorder, Watson said Tuesday.

Watson entered an agreement with Johnson & Johnson subsidiary Ortho-McNeil-Janssen Pharmaceuticals to distribute an authorized generic of Concerta (methylphenidate hydrochloride) extended-release tablets. An authorized generic is a branded drug sold under its generic name, usually by a third-party company.

October 25, 2010

Strativa Pharmaceuticals is working with a Swedish drug maker to develop and commercialize a prescription...

WOODCLIFF LAKE, N.J. Strativa Pharmaceuticals is working with a Swedish drug maker to develop and commercialize a prescription vitamin supplement, Strativa said Tuesday.

 

The company said it had signed a license and supply agreement with Swedish Orphan Biovitrum, also known as Sobi, concerning European rights to Strativa’s Nascobal (cyanocobalamin), a vitamin B12 nasal spray.

 

 

October 4, 2010

Ranbaxy has won the right to sell a generic version of an Alzheimer’s disease drug...

NEW YORK Ranbaxy has won the right to sell a generic version of an Alzheimer’s disease drug made by Eisai, according to published reports.

Bloomberg reported Tuesday that the Indian drug maker had won 180 days’ exclusivity in which to market a generic version of Eisai’s Aricept (donepezil hydrochloride) tablets, pending final Food and Drug Administration approval, beating out Israel-based Teva Pharmaceutical Industries.

September 29, 2010

Teva Pharmaceutical Industries and OncoGenex Pharmaceuticals have started a late-stage clinical trial of an investigative...

BOTHELL, Wash. Teva Pharmaceutical Industries and OncoGenex Pharmaceuticals have started a late-stage clinical trial of an investigative treatment for advanced prostate cancer, the two companies said Thursday.

 

Teva and OncoGenex, a company based in the Seattle suburb of Bothell, Wash., that develops cancer therapies, announced the start of “SYNERGY,” a phase-3 trial of OGX-011/TV-1011 (custirsen), a first-line therapy for treating castrate-resistant prostate cancer.

 

 

September 21, 2010

Merck is expanding its patient assistance program, the drug maker said Wednesday....

WHITEHOUSE STATION, N.J. Merck is expanding its patient assistance program, the drug maker said Wednesday.

September 21, 2010

The Food and Drug Administration has approved a drug for reducing relapses in patients with...

SILVER SPRING, Md. The Food and Drug Administration has approved a drug for reducing relapses in patients with multiple sclerosis.

 

The FDA announced Wednesday the approval of Swiss drug maker Novartis’ Gilenia (fingolimod) capsules, saying it was the first oral drug that can slow the progression of disability in patients with MS and offered an alternative to injected drugs.

 

 

Around 400,000 people in the United States and 2.1 million worldwide have MS, according to the National Multiple Sclerosis Society.

August 29, 2010

BioMarin Pharmaceutical on Monday announced its investigational treatment for a lysosomal storage disorder has received...

August 25, 2010

The Food and Drug Administration has accepted an application from Sanofi Pasteur to expand the...

SWIFTWATER, Pa. The Food and Drug Administration has accepted an application from Sanofi Pasteur to expand the use of a vaccine in children.

Sanofi Pasteur, the vaccines division of French drug maker Sanofi-Aventis, announced Thursday the FDA’s acceptance of its application seeking approval of Menactra (meningococcal [groups A, C, Y and W-135] polysaccharide diphtheria toxoid conjugate vaccine) for active immunizations of infants and toddlers against invasive meningococcal disease.

August 19, 2010

BioMarin Pharmaceutical has acquired privately owned biotechnology company ZyStor Therapeutics for $22 million, BioMarin said....

August 18, 2010

Swiss drug maker Biogen Idec will develop and commercialize an investigational drug as a treatment...

August 5, 2010

The Food and Drug Administration has approved a new formulation of a chemotherapy drug made...

July 22, 2010

An investigational drug for rheumatoid arthritis reduced the duration of symptoms in patients over the...

July 21, 2010

An investigational treatment for HIV made by Johnson & Johnson subsidiary Tibotec Pharmaceuticals works as...

July 18, 2010

A Johnson & Johnson pain drug produced fewer side effects in patients than oxycodone, according...

July 14, 2010

The Food and Drug Administration has given special designation to an investigational treatment for a...

July 13, 2010

The market for multiple sclerosis drugs, long dominated by biologics and injectables, soon could see...

July 5, 2010

The Food and Drug Administration has approved a preventive treatment made by Strativa Pharmaceuticals for...

June 24, 2010

French drug maker Sanofi-Aventis has made a deal with U.S. drug maker Metabolex to license...

June 21, 2010

The Food and Drug Administration has approved a new test for detecting HIV antigen and...

June 16, 2010

An investigational drug for lupus that could become the first new treatment for the disease...