Specialty Pharmacy

RARITAN, N.J. — The Food and Drug Administration has approved a drug made by Johnson & Johnson for treating deep vein thrombosis in patients undergoing knee or hip replacement surgery, a J&J subsidiary said Friday.

Janssen Pharmaceuticals announced the approval of Xarelto (rivaroxaban) tablets as a once-daily oral anticoagulant for DVT, a condition that could lead to pulmonary embolism.

FLINT, Mich. — Just about everybody seems satisfied with Diplomat Specialty Pharmacy’s services, according to the company’s 2011 patient satisfaction survey.

Diplomat mailed the survey to 1,545 customers in May, of whom 463 responded. Of those respondents, 90% said Diplomat exceeded their expectations; 98% said it met their expectations; and 99% said they were satisfied overall with the specialty pharmacy provider.

Diplomat president and CEO Phil Hagerman said the results affirmed the provider’s patient-focused model.

LOS ANGELES — A group of physicians is urging the Food and Drug Administration not to approve a drug made by Gilead Sciences for the prevention of HIV infection.

Fifty-five physicians signed a letter spearheaded by the AIDS Healthcare Foundation citing concerns about the use of Gilead’s Truvada (tenofovir disoproxil fumarate and emtricitabine) for “pre-exposure prophylaxis,” or PrEP. Concerns included the risk of a decrease in condom use and a lack of information showing proper use in “real world” situations.

ALLEGAN, Mich. — Perrigo on Wednesday announced that its closing date to complete the acquisition of Paddock Labs — a generic pharmaceutical and specialty over-the-counter products manufacturer — has been delayed by an extended Federal Trade Commission review.

INDIANAPOLIS — A topical drug made by Eli Lilly restored testosterone to normal levels in men with abnormally low testosterone, according to results of a late-stage clinical trial.

Lilly announced results of a phase-3 trial of Axiron (testosterone) topical solution, a treatment for the condition, also known as hypogonadism. Study results also showed that the drug improved symptoms associated with it.

Hypogonadism results from damage or disease of the testicles, hypothalamus or pituitary glands that inhibits production of testosterone.

MONMOUTH JUNCTION, N.J. — A specialty pharmaceutical company has appointed a new VP human resources.

Cheryl Patnick, who has more than 20 years of experience in human resources and mergers/acquisitions, will lead and manage Tris Pharma's human resource activities, the company said Wednesday.

CORK, Ireland — A subsidiary of Johnson & Johnson and Gilead Sciences will collaborate to develop a combination drug for HIV, the two companies said Tuesday.

Gilead and Tibotec Pharmaceuticals will work to create a once-daily, single-tablet combination of Tibotec’s Prezista (darunavir) and Gilead’s investigational drug cobicistat, a so-called boosting agent.

CHADDS FORD, Pa. — The Food and Drug Administration has accepted a resubmission by Endo Pharmaceuticals of a regulatory application for an opioid pain drug designed to thwart abuse, Endo said.

The agency had declined to approve Endo’s Opana ER (oxymorphone hydrochloride) in January for reasons that the company did not specify, though the agency did not request additional clinical studies in its statement, known as a complete response letter.