Content about Hematology

SILVER SPRING, Md. — The Food and Drug Administraiton has approved a treatment for replacing clotting proteins in the blood for conditions in which patients have too little of them.

The FDA announced the approval of Octapharma's Octaplas, a sterile, frozen solution of pooled human plasma from multiple donors that has been treated with a solvent detergent process.

PHILADELPHIA – Recent research from the Rothman Institute at Jefferson has shown aspirin to be just as effective in preventing clots — specifically pulmonary emboli, life-threatening blood clots that can develop in the arteries of the lungs following joint replacement surgery — Thomas Jefferson University announced Wednesday. 

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug for treating a rare type of leukemia, the agency said Thursday.

The FDA approved South San Francisco, Calif.-based Talon Therapeutics' Marqibo (vincristine sulfate liposome), an injectable drug for Philadelphia chromosome-negative acute lymphoblasic leukemia, or Ph-negative ALL.

CINCINNATI — Days after its acquisition of Coagulife, specialty pharmacy provider BioRx has received limited distribution rights to a treatment for a bleeding disorder described as one of the rarest in the world.

The company, which specializes in treating bleeding disorders, said Wednesday that it had received the rights for Corifact (factor XIII concentrate [human]), a treatment made by CSL Behring for congenital Factor XIII deficiency. The drug received approval from the Food and Drug Administration in February 2011.

RARITAN, N.J. — Drug maker Johnson & Johnson is seeking approval from the Food and Drug Administration for a drug to treat patients with deep vein thrombosis or pulmonary embolism, the company said.

J&J division Janssen Research & Development announced the submission of a supplemental new drug application for Xarelto (rivaroxaban) to the FDA for the two conditions and for preventing recurrent venous thromboembolism.

SILVER SPRING, Md. — Sunpeaks Ventures last week announced national advertising support behind its Clotamin multivitamin line — a line of supplements formulated for use by patients on warfarin or other blood thinners.

"Until now, Clotamin has never been the focus of any consumer marketing," stated Mackie Barch, Sunpeaks CEO. "The product's popularity has been built solely through positive word of mouth from our customers and through pharmacies that already carry the product."

ATLANTA — Meda Consumer Healthcare last week featured three revitalized Feosol SKUs, which are set to launch at retail in May, at the ECRM Vitamin, Diet & Sports Nutrition EPPS conference.

The lineup lends itself to a good-better-best merchandising strategy in what has been a commoditized category, and the marketing plan in place to support the launch will mean a significant uptick in promotion of iron supplementation.

HOBOKEN, N.J. — A drug for treating immune system disorders is available again following a voluntary market withdrawal last summer.

Octapharma USA said Wednesday that Octagam (immune globulin intravenous [human] 5% liquid preparation) again was available for purchase. The Food and Drug Administration approved its reintroduction on Nov. 3.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new chemotherapy drug for treating acute lymphoblastic leukemia, the agency said Friday.

The FDA announced the approval of EUSA Pharma's Erwinaze (asparaginase Erwinia chrysanthemi) to treat patients with ALL who have developed an allergy to E. coli-derived asparaginase and pegaspargase chemotherapy drugs.

HOBOKEN, N.J. — The Food and Drug Administration has cleared the way for the return to market of a drug for treating immunodeficiency diseases following its recall by the manufacturer in response to patients developing internal blood clots.

SILVER SPRING, Md. — The Food and Drug Administration has approved a treatment made by Alexion Pharmaceuticals for a rare blood disorder that affects children.

The FDA announced the approval of Soliris (eculizumab) for atypical hemolytic uremic syndrome, a rare and chronic disease that can lead to kidney failure, stroke and death. According to the FDA, aHUS accounts for 5% to 10% of all cases of hemolytic uremic syndrome.

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.