Content about Clinical research

SILVER SPRING, Md. — The Food and Drug Administration has accepted the resubmission of a regulatory approval application from United Therapeutics for a drug to treat pulmonary arterial hypertension, the drug maker said Thursday.

The FDA originally declined to approve the drug, treprostinil diolamine extended-release tablets, in a letter submitted to the company in October 2012.

The agency plans to decide whether or not to approve the drug in March of this year, United Therapeutics said.

MCLEAN, Va. — Unexpected toxicities from prescription drugs that emerge years after regulatory approval may be due to poor medication adherence in clinical trials, according to a new study.

While much attention on medication adherence has focused on patients not taking the already approved drugs prescribed to them or not taking them properly, the new study, released Tuesday by Consumer Health Information, found problems with adherence in clinical trials as well.

NEW YORK — GlaxoSmithKline may be looking to buy a Brazilian drug maker for up to $4 billion, according to published reports.

Reuters, citing unnamed sources, said GSK was one of several drug companies looking to buy Ache Laboratorios Farmaceuticos for $3 billion to $4 billion. Other companies looking to buy the drug maker included Novartis, Pfizer and Abbott Labs.

Reuters noted that the company was attractive to drug makers looking to expand their footprints in Latin America and that it was a major producer of prescription and OTC medications.

 SILVER SPRING, Md. - The Food and Drug Administration has given tentative approval to a generic drug for treating hypertension, according to agency records.

The FDA granted tentative approval to Dr. Reddy's Labs' valsartan tablets in the 40 mg, 80 mg, 160 mg and 320 mg strengths.

The drug is a generic version of Novartis' Diovan. Various versions of the drug had sales of $1.6 billion during the 12-month period that ended in June, according to IMS Health.

NORTHVALE, N.J. — The Food and Drug Administration has approved a regulatory approval application from Elite Pharmaceuticals for an opioid painkiller, the drug maker said Wednesday.

Elite announced the FDA approval of its supplemental application for the manufacture and packaging of naltrexone hydrochloride tablets in the 50-mg strength. The company said the approval would allow it to start manufacturing and packaging the drug for its sales and marketing partner, Mikah Pharma, from which it bought rights to the drug in September 2010.

NEW YORK — Republican and Democratic senators have re-introduced legislation that would ban patent settlements between branded and generic drug companies that critics allege violate antitrust laws, according to published reports.

SILVER SPRING, Md. — The Food and Drug Administration has approved a generic version of a cancer drug in a move that the agency said would help relieve shortages.

The FDA announced the approval of Sun Pharma Global's doxorubicin hydrochloride liposome injection, a generic version of Johnson & Johnson's Doxil. The drug is currently on the agency's list of drugs experiencing shortages.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug for treating some disorders that harm the body's ability to remove ammonia from the blood, the agency said Friday.

NEW YORK — The Food and Drug Administration has approved a new use for a pneumococcal vaccine made by Pfizer, the drug maker said.

Pfizer announced the approval of Prevnar 13 (pneumococcal 13-valent conjugate vaccine [diphtheria CRM197 protein]) for children and adolescents ages 6 years to 17 years for active immunization against the 13 Streptococcus pneumonia serotypes the vaccine covers. For this group, Prevnar 13 is administered as a one-time dose to patients who have never received it.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new use for a cancer drug made by Roche unit Genentech, the agency said.

The FDA announced the approval of Avastin (bevacizumab) combined with fluoropyrimidine-irinotecan or fluoropyrimidine-oxaliplatin chemotherapy for treating colorectal cancer that has spread to other parts of the body, also known as metastatic colorectal cancer, or mCRC.

The drug is also approved for treating lung cancer, kidney cancer and brain cancer.

BALTIMORE — The Food and Drug Administration has approved a generic contraceptive made by Lupin Pharmaceuticals, the drug maker said Tuesday.

Lupin announced the approval of levonorgestrel and ethinyl estradiol tablets in the 0.1 mg/0.02 mg strength, a generic version of Watson Labs' Lutera.

Lutera had sales of about $103.6 million during the 12-month period that ended in September 2012, according to IMS Health.

NEW YORK — While regulations for biosimilars work their way through the Food and Drug Administration, state governments are already looking at legislation concerning the substitution of biosimilars for their branded counterparts, according to a legal affairs blog focused on the FDA.

In a post Friday on FDA Law Blog, the official blog of the law firm Hyman, Phelps & McNamara, attorney Kurt Karst wrote that several states were laying the groundwork for such legislation, recalling state-level antisubstitution laws targeting generics that were adopted in the 1970s.