Content about Clinical research

November 5, 2012

The Food and Drug Administration has approved a drug made by Johnson & Johnson for treating internal blood clots, the company said.

RARITAN, N.J. — The Food and Drug Administration has approved a drug made by Johnson & Johnson for treating internal blood clots, the company said.

J&J subsidiary Janssen Pharmaceuticals announced the approval of Xarelto (rivaroxaban) for treating deep-vein thrombosis and pulmonary embolism and to reduce the risk of recurrence of the clotting conditions after initial treatment.

The company said Xarelto was the first oral anticoagulant approved to treat DVT and PE without the need for injections or routine blood-monitoring.

November 5, 2012

The Food and Drug Administration has approved a generic drug for treating blood pressure and chest pain.

FDA approves cardiovascular drug

MORRISTOWN, N.J. — The Food and Drug Administration has approved a generic drug for treating blood pressure and chest pain. Actavis announced the approval of diltiazem hydrochloride extended-release capsules.
The drug is a generic version of Valeant’s Tiazac. The branded drug and its generic equivalents had sales of about $76.3 million in 2011, according to IMS Health.



November 1, 2012

Some generic drugs may come under more scrutiny from the Food and Drug Administration amid reports that the generic version of a treatment for depression didn't work as well as the branded version, according to published reports.

NEW YORK – Some generic drugs may come under more scrutiny from the Food and Drug Administration amid reports that the generic version of a treatment for depression didn't work as well as the branded version, according to published reports.

October 31, 2012

Generic drug maker Sandoz has started a late-stage clinical trial in the United States for a biosimilar treatment for anemia, the company said.

HOLZKIRCHEN, Germany — Generic drug maker Sandoz has started a late-stage clinical trial in the United States for a biosimilar treatment for anemia, the company said.

Sandoz, the generics arm of Swiss drug maker Novartis, said it had started enrolling patients for a phase-3 study of epoetin alfa, a biosimilar version of Epogen and Procrit, made by Amgen and Johnson & Johnson and used to treat anemia associated with chronic kidney disease.

October 29, 2012

The Food and Drug Administration has approved a Type 2 diabetes drug made by Watson Pharmaceuticals, the company said, following a federal court's order for the agency to approve the drug.

PARSIPPANY, N.J. – The Food and Drug Administration has approved a Type 2 diabetes drug made by Watson Pharmaceuticals, the company said, following a federal court's order for the agency to approve the drug.

Watson announced the launch of pioglitazone hydrochloride tablets in the 15-mg, 30-mg and 45-mg strengths. The drug is a generic version of Takeda's Actos, branded and generic versions of which had sales of about $2.7 billion during the 12-month period ended in August, according to IMS Health.

October 26, 2012

The Food and Drug Administration has approved what it called the second new drug in two months for a form of leukemia, the agency said Friday.

SILVER SPRING, Md. — The Food and Drug Administration has approved what it called the second new drug in two months for a form of leukemia, the agency said Friday.

The FDA announced the approval of Teva Pharmaceutical Industries' Synribo (omacetaxine mepesuccinate) for chronic myelogenous leukemia, or CML, a disease that the National Institutes of Health expects will be diagnosed in more than 5,400 people this year. The drug is intended for patients whose disease has progressed after treatment with at least two drugs of a class used to treat the disease.

October 26, 2012

The Food and Drug Administration on Thursday announced a pair of penal actions against companies operating outside of dietary supplement regulations.

 SILVER SPRING, Md. — The Food and Drug Administration on Thursday announced a pair of penal actions against companies operating outside of dietary supplement regulations. 

A federal judge granted the FDA a permanent injunction against Truman Berst, doing business as Alternative Health & Herbs Remedies of Albany, Ore., for selling products represented as herbs and supplements with claims for treating diseases.

October 26, 2012

The Food and Drug Administration said it found a number of problems with cleanliness at a compounding pharmacy linked to a meningitis outbreak that has so far sickened hundreds of people and killed two dozen in a report released Friday.

SILVER SPRING, Md. — The Food and Drug Administration said it found a number of problems with cleanliness at a compounding pharmacy linked to a meningitis outbreak that has so far sickened hundreds of people and killed two dozen in a report released Friday.

October 25, 2012

The Food and Drug Administration has approved a generic drug for leukemia made by a subsidiary of Par Pharmaceutical Cos.

WOODCLIFF LAKE, N.J. — The Food and Drug Administration has approved a generic drug for leukemia made by a subsidiary of Par Pharmaceutical Cos.

Par said Thursday that the FDA had approved Anchen Pharmaceuticals' tretinoin capsules in the 10-mg strength.

The drug is a generic version of Roche's Vesanoid, various versions of which have annual sales of about $29 million, according to IMS Health.

October 25, 2012

The Food and Drug Administration has declined to approve a drug developed by United Therapeutics Corp. for treating a potentially lethal high blood pressure condition.

SILVER SPRING, Md. — The Food and Drug Administration has declined to approve a drug developed by United Therapeutics Corp. for treating a potentially lethal high blood pressure condition.

The drug maker said it received a complete response letter from the agency for its application for a tablet formulation of the drug treprostinil. The company already markets the drug in injectable and inhaled formulations for pulmonary arterial hypertension, or PAH, a condition that causes high blood pressure in the arteries of the lungs.

October 24, 2012

Mylan is challenging a federal court decision ordering the Food and Drug Administration to allow Watson Pharmaceuticals to launch a generic diabetes drug, Mylan said.

PITTSBURGH — Mylan is challenging a federal court decision ordering the Food and Drug Administration to allow Watson Pharmaceuticals to launch a generic diabetes drug, Mylan said.

The generic drug maker said it filed a motion in the U.S. District Court for the District of Columbia Tuesday to stay the court's order, which called on the FDA to let Watson launch a generic version of Takeda's Type 2 diabetes drug Actos (pioglitazone).

October 23, 2012

A federal court has ordered the Food and Drug Administration to approve a generic diabetes drug made by Watson Pharmaceuticals, the drug maker said.

PARSIPPANY, N.J. — A federal court has ordered the Food and Drug Administration to approve a generic diabetes drug made by Watson Pharmaceuticals, the drug maker said.

Watson said the U.S. District Court for the District of Columbia granted summary judgment in favor of Watson, ruling that the FDA would have to approve its generic version of Takeda's Actos (pioglitazone hydrochloride) tablets in the 15-mg, 30-mg and 45-mg strengths.

October 23, 2012

The Food and Drug Administration is expected to decide at the end of this week whether to approve a new oral drug for pulmonary arterial hypertension made by United Therapeutics.

NEW YORK — The Food and Drug Administration is expected to decide at the end of this week whether to approve a new oral drug for pulmonary arterial hypertension made by United Therapeutics.

October 22, 2012

More patients with an inflammatory disease of the bowels responded to a drug used for autoimmune disorders than those taking a placebo, according to results of a late-stage clinical trial announced Monday.

LAS VEGAS — More patients with an inflammatory disease of the bowels responded to a drug used for autoimmune disorders than those taking a placebo, according to results of a late-stage clinical trial announced Monday.

Johnson & Johnson said phase-3 trial findings showed that "significantly" more patients with severely active ulcerative colitis responded to Simponi (golimumab), maintaining their responsiveness to the drug through the 54th week. The drug is already approved by the Food and Drug Administration for treating conditions like rheumatoid arthritis.

October 19, 2012

British researchers have concluded that a Swiss echinacea extract is both safe and effective in helping to prevent symptoms of the common cold, according to a study published in American Botanical Council's peer-reviewed journal HerbalGram.

AUSTIN, Texas — British researchers have concluded that a Swiss echinacea extract is both safe and effective in helping to prevent symptoms of the common cold, according to a study published in American Botanical Council's peer-reviewed journal HerbalGram

October 19, 2012

The Food and Drug Administration has given tentative approval to a new drug for HIV made by an Indian company.

SILVER SPRING, Md. — The Food and Drug Administration has given tentative approval to a new drug for HIV made by an Indian company.

FDA records show that the agency gave tentative approval tablets and oral suspension that combine lamivudine, nevirapine and zidovudine in the 30-mg/50-mg/60-mg strength.

October 18, 2012

The Food and Drug Administration has approved what it called the first drug to treat an eye condition that can interfere with the part of the retina responsible for reading vision.

SILVER SPRING, Md. — The Food and Drug Administration has approved what it called the first drug to treat an eye condition that can interfere with the part of the retina responsible for reading vision.

The agency announced the approval of Jetrea (ocriplasmin), made by Iselin, N.J.-based ThromboGenics. The drug is used to treat symptomatic vitreomacular adhesion.

October 18, 2012

The Food and Drug Administration has approved a generic contraceptive made by Indian drug maker Lupin, the company said Thursday.

MUMBAI, India — The Food and Drug Administration has approved a generic contraceptive made by Indian drug maker Lupin, the company said Thursday.

Lupin announced the approval of Kurvelo (levonorgestrel and ethinyl estradiol) tablets in the 0.15 mg/0.03 mg strength.

The drug is a generic version of Teva's branded Nordette. Nordette had sales of about $59 million during the 12-month period ended in June, according to IMS Health.

October 18, 2012

SoloHealth on Thursday announced it has plans in place to expand its FDA-approved SoloHealth Station health-and-wellness digital kiosks to more than 2,500 store locations by mid-2013, scaling to more than 4,000 by 2014.

ATLANTA, Ga. — SoloHealth on Thursday announced it has plans in place to expand its FDA-approved SoloHealth Station health-and-wellness digital kiosks to more than 2,500 store locations by mid-2013, scaling to more than 4,000 by 2014. 

October 17, 2012

The Food and Drug Administration has accepted a regulatory approval application for a drug for hot flashes from Depomed, the drug maker said.

MENLO PARK, Calif. — The Food and Drug Administration has accepted a regulatory approval application for a drug for hot flashes from Depomed, the drug maker said.

Depomed submitted its application to the FDA for Serada (gabapentin), an extended-release drug for hot flashes in menopausal women.

October 15, 2012

The Food and Drug Administration may be willing to speed up trials for drugs that could be a big benefit to society despite their risks.

SILVER SPRING, M.D. — The Food and Drug Administration may be willing to speed up trials for drugs that could be a big benefit to society despite their risks.

According to several published reports, FDA commissioner Margaret Hamburg recently told a group of scientific advisers that the agency is considering allowing makers of drugs having a societal benefit to conduct faster clinical trials with a smaller group of patients than is now required.

October 12, 2012

The Food and Drug Administration has approved an injected drug for lung cancer made by Celgene, the company said Friday.

SUMMIT, N.J. — The Food and Drug Administration has approved an injected drug for lung cancer made by Celgene, the company said Friday.

Celgene announced the approval of Abraxane (paclitaxel) protein-bound particles for injectable suspension, for the first-line treatment of non-small cell lung cancer that has advanced locally or spread to other parts of the body, in combination with carboplatin, for patients who are not candidates for curative surgery or radiation therapy.

October 12, 2012

The Food and Drug Administration has approved a new use for a drug made by Roche division Genentech.

SOUTH SAN FRANCISCO, Calif. — The Food and Drug Administration has approved a new use for a drug made by Roche division Genentech.

The drug maker said Friday that the FDA had approved Actemra (tocilizumab) for adults with moderately to severely active rheumatoid arthritis who have not responded adequately to one or more disease-modifying antirheumatic drugs. The drug was already approved for systemic juvenile idiopathic arthritis.

October 12, 2012

The Food and Drug Administration has approved a drug made by Sandoz for treating symptoms of various skin diseases.

PRINCETON, N.J. — The Food and Drug Administration has approved a drug made by Sandoz for treating symptoms of various skin diseases.

Sandoz, the generics arm of Swiss drug maker Novartis, announced the approval of desoximetasone ointment in the 0.25% strength. The drug is a generic version of Taro Pharmaceutical Industries' Topicort and, according to Sandoz, is the first Fougera dermatology product Sandoz has launched since its $1.5 billion acquisition of the company in May 2012.

October 10, 2012

The Food and Drug Administration has approved a generic drug for treating blood pressure and chest pain.

MORRISTOWN, N.J. — The Food and Drug Administration has approved a generic drug for treating blood pressure and chest pain.

Actavis announced Wednesday the approval of diltiazem hydrochloride extended-release capsules.

The drug is a generic version of Valeant's Tiazac. The branded drug and its generic equivalents had sales of about $76.3 million in 2011, according to IMS Health.