Content about Clinical research

NEW YORK — Florida's state legislature approved a bill last week that will allow pharmacists to substitute biosimilars for brand name biotech drugs.

The bill, which was approved last Tuesday and is scheduled to take effect on July 1, institutes requirements for pharmacists to substitute biosimilars when they are determined to be biosimilar to and interchangeable with the brand name product, while also requiring the state board of pharmacy to maintain a current list of interchangeable products.

WASHINGTON — The Justice Department late Wednesday reported it will appeal a recent judicial decision that would require removing any age restriction from the purchase of the Plan B emergency contraceptive, according to a report published in USA Today.

HYDERABAD — The Food and Drug Administration has approved two generic drugs made by Aurobindo Pharma, the drug maker said.

The company announced Tuesday the approval of quinapril tablets in the 5-mg, 10-mg, 20-mg and 40-mg strengths. The drug is a generic version of Pfizer's Accupril and is used to treat high blood pressure. Various versions of the drug had sales of about $49 million during the 12-month period ending in September, according to IMS Health.

SILVER SPRING, Md. — The Food and Drug Administration has approved a drug that reverses the effects of anticoagulant drugs in patients who have suffered acute major bleeding, the agency said.

The FDA announced the approval of CSL Behring's Kcentra (prothrombin complex concentrate [human]) for the urgent reversal of vitamin K antagonist, or VKA drugs such as warfarin.

SILVER SPRING, Md. — A Food and Drug Administration staffer who has led implementation of the Generic Drug User Fee Act has been named to a new director position at the agency, the FDA said Monday.

The FDA announced that it had appointed Mary Beth Clarke as permanent director of the Office of Executive Programs. Clarke had previously served as the OEP's executive director.

CHICAGO — Generic drug maker Hospira marked its fifth year marketing knock-off versions of biotech drugs in Europe Wednesday as it presented at the 2013 Biotechnology Industry Organization International Convention this week.

The drug maker said it delivered more than 5 million doses of biosimilar medicines to patients in Europe and Australia. The convention includes multiple sessions devoted to such topics as biosimilar regulatory approval, manufacturing and market formation, the company said.

DUBLIN — The Food and Drug Administration has approved a new contraceptive drug made by Warner Chilcott, the drug maker said.

Warner Chilcott announced the approval of Minastrin 24 FE (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules) for prevention of pregnancy.

The drug maker said an unnamed third-party company would manufacture the drug, but it did not expect to launch it this year.

DUBLIN — The Food and Drug Administration has approved a new strength of an antibiotic made by Warner Chilcott, the drug maker said.

Warner Chilcott announced the approval of the 200-mg strength of Doryx (doxycycline hyalite) delayed-release tablets, which the company plans to release in July 2013.

Doryx delayed-release tablets are already available in the 75-mg, 100-mg and 150-mg strengths.

SILVER SPRING, Md. — Two Dallas-based compounding pharmacies announced a recall of sterile drug products made at their facilities due to production conditions that could lead to contamination.

The Food and Drug Administration said Tuesday that ApotheCure had recalled all sterile drug products made at its pharmacy, while NuVision Pharmacy had recalled sterile freeze-dried or lyophilized drug products made at its facility. Both recalls were described as voluntary.

SAN DIEGO — The Food and Drug Administration is granting an expedited application process to a company that has developed a treatment for a condition related to Parkinson's disease, meaning that it can cancel a planned late-stage clinical trial, the company said.

NEW YORK — An experimental drug developed by AstraZeneca for rheumatoid arthritis produced mixed results in measurements of patients' conditions, according to results of a late-stage clinical trial.

AstraZeneca announced initial results of the phase-3 "OSKIRA-1" trial of fostamatinib, which it calls the first oral spleen tyrosine kinase inhibitor in development for RA.

HYDERABAD, India — The Food and Drug Administration has given preliminary approval to a drug made by Aurobindo Pharma for treating HIV infection in developing countries, the drug maker said.

Aurobindo announced that it had received tentative approval for efavirenz/emtricitabine/tenofovir disoproxil fumarate combination tablets in the 600-mg/200 mg/300-mg strength. The drug is a generic version of Gilead Sciences' Atripla.