SUPPLIER NEWS — 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. 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.
Dr. Reddy’s Labs has launched a generic drug for treating high blood pressure, the company said. Dr. Reddy’s announced the launch of amlodipine besylate and benazepril hydrochloride capsules in the 5-mg/40-mg and 10-mg/40-mg strengths. The drug is a generic version of Novartis’ Lotrel, which had sales of $290 million during the 12-month period ended in March, according to IMS Health.
The FDA has approved a new drug for preventing organ rejection in kidney transplant patients, the agency said. The FDA approved Bristol- Myers Squibb’s Nulojix (belatacept) for preventing acute rejection in adult patients. The drug is approved for use with other immune system- suppressing drugs, specifically Novartis’ Simulect (basiliximab), Genentech’s CellCept (mycophenolate mofetil) and corticosteroids.
The FDA has approved a drug made by Archimedes Pharma for treating breakthrough pain in cancer patients, Archimedes said. Archimedes announced the approval of Lazanda (fentanyl) nasal spray for cancer patients who have acquired a tolerance to opioid drugs. Breakthrough pain is an intense, sudden pain that is unpredictable and often debilitating, and occurs despite appropriate pain therapy.
Wockhardt has launched three new drugs in the United States in just three weeks, the Indian generic drug maker said. Wockhardt announced the FDA’s approval and the launch of the company’s antibacterial drug levofloxacin, a generic version of Johnson & Johnson’s Levaquin, in the 250-mg, 500-mg and 750-mg strengths.
On May 31, the company launched donepezil tablets, a generic version of Eisai’s Alzheimer’s disease drug Aricept. On June 1, it launched venlafaxine extended-release capsules, a generic version of Pfizer antidepressant Effexor XR. Branded versions of the three drugs have combined sales of $6 billion, according to IMS Health.