Content about Chemistry

NEW YORK — Drug maker Otsuka Pharmaceuticals can keep generic versions of its schizophrenia drug off the market, according to published reports.

Bloomberg reported that the Supreme Court upheld a ruling that allowed Otsuka to block Canadian generic drug maker Apotex from marketing a version of the antipsychotic Abilify (aripiprazole), which Otsuka co-markets with Bristol-Myers Squibb.

NEW YORK — While replacing a single combination pill for HIV with generics would save the healthcare system money, it could also diminish the effectiveness of treatment, a new study suggests.

The study, led by investigators at the Massachusetts General Hospital and Weill Cornell Medical College, and published in the Jan. 15 issue of Annals of Internal Medicine, found $1 billion in potential savings, but the more complicated treatment regimen might result in more patients missing doses and a loss of drug effectiveness.

SILVER SPRING, Md. — The Food and Drug Administration is ordering the makers of several sleep drugs to lower the recommended dosage due to the risk that they can impair patients the morning after, the agency said Thursday.

The FDA announced that it was requiring the manufacturers of drugs containing the active ingredient zolpidem to lower the current recommended dosage in light of new data showing that the morning after use, the drug can remain in the blood in sufficient quantities to impair activities that require alertness, such as driving.

WASHINGTON — The Council for Responsible Nutrition on Tuesday announced the addition of eight new members, including voting members Church & Dwight and P.J. Noyes Co., along with associate members AIBMR Life Sciences, Bell Advisory Services, Biofortis, Creative Flavor Concepts and Nutrasource Diagnostics.

CINCINNATI, Ohio — Drug maker Prasco Labs has launched an authorized generic version of a drug used to treat heavy menstrual bleeding, the company said Monday.

Prasco announced the launch of tranexamic acid tablets in the 650 mg strength, an authorized generic version of Ferring Pharmaceuticals' Lysteda. Authorized generics are branded drugs marketed under their generic names at a discount, usually through third-party companies, to compete with Food and Drug Administration-approved generics.

WASHINGTON — A court has ruled in favor of Indian generic drug maker Ranbaxy Labs in a case concerning a generic blood pressure drug, the legal firm representing the drug maker said.

Zuckerman Spaeder LLP said the U.S. District Court for the District of Columbia upheld a Food and Drug Administration decision protecting Ranbaxy's market exclusivity for a generic version of Novartis' drug Diovan (valsartan).

SPRING SPRING, Md. — The U.S. Food and Drug Administration on Monday approved Fulyzaq (crofelemer) to relieve symptoms of diarrhea in HIV/AIDS patients taking antiretroviral therapy, a combination of medicines used to treat HIV infection. Diarrhea is experienced by many HIV/AIDS patients and is a common reason why patients discontinue or switch their antiretroviral therapies.

SILVER SPRINGS, Md. — Teva Pharmaceuticals has received approval of their new drug application for topotecan hydrochloride injection, a treatment for small cell lung cancer, according to Food and Drug Administration records.

PITTSBURGH — Mylan on Friday announced that its partner Famy Care has received final approval from the U.S. Food and Drug Administration for its abbreviated new drug application for levonorgestrel and ethinyl estradiol tablets USP in the 0.15mg/0.03mg strength.

The product is a generic version of Teva Branded Pharmaceutical Products' Nordette 28 Tablets, a form of oral contraception. The new product will be distributed in the United States by Mylan Pharmaceuticals, and the company is shipping the product immediately.

PARSIPPANY, N.J. — Watson Pharmaceuticals on Friday confirmed that Actavis, which was acquired by Watson in October, has filed an abbreviated new drug applications with the U.S. Food and Drug Administration seeking approval to market bortezomib, a generic version of Millennium Pharmaceuticals' Velcade.

Bortezomib is a proteasome inhibitor for intravenous or subcutaneous administration, approved for treatment of patients with multiple myeloma and patients with mantle cell lymphoma who have received at least one prior therapy.

CHADDS FORD, Pa. — A federal court decision means that a nontamper-resistant formulation of a painkiller made by Endo Health Solutions can enter the market early next month, the drug maker said.

The U.S. District Court for the District of Columbia dismissed a case filed by Endo subsidiary Endo Pharmaceuticals against the Food and Drug Administration, in which the company had argued that the FDA failed meet a legal obligation to determine whether the original formulation of Opana ER (oxymorphone) extended-release tablets was withdrawn from the market for safety reasons.