FDA is looking closely at anemia drug evidence
WASHINGTON The Food and Drug Administration is questioning the evidence used to support an anemia drug made by Amgen and Johnson & Johnson. Anemia is a deficiency of red blood cells.
The FDA has said it found “important deficiencies” in material that is being used to prove the drugs improve quality of life for anemic kidney disease patients by boosting their energy. The names of the drugs are Epogen and Aranesp, manufactured by Amgen and Procrit by Johnson and Johnson.
The agency is also questioning the proper dosage for the drugs when given to patients who are suffering from kidney failure. High doses of the drugs have been linked to cardiovascular and cancer-related risks.
Medicare will be watching this outcome closely as they have also expressed concerns regarding dosages and are stating that they will limit coverage depending on dosage requirements.
Teva announces shipment of generic Famvir
Teva Pharmaceutical Industries Ltd. has begun the shipment of its generic version of Novartis’ Famvir herpes treatment, the company said Friday.
As the first drug developer to file for a generic version of the drug, famciclovir, Teva has been awarded a 180-day period of marketing exclusivity.
The announcement comes two days following the U.S. District Court in New Jersey’s decision to deny Novartis’ motion for a preliminary injunction, which would have prevented Teva from marketing its version of Famvir.
During afternoon trading, shares of the Israeli company fell 11 cents to $43.39, while Novartis’ American Depositary Shares rose 8 cents to $53.41.
In 2006, Famvir net sales totaled at $166 million in the United States.
Actavis’ generic Norvasc gets approval from FDA
NEW YORK The Food and Drug Administration approved Actavis Group’s generic version of a well-known high blood pressure medication, the company announced Friday.
The company said they were given the go-ahead to develop amlodipine besylate tablets, the generic form of Pfizer’s Norvasc. The medication will be available in 2.5, 5 and 10 mg doses.
Actavis, one of the leading generic pharmaceutical companies in the world, operates in close to 40 countries, and continues to expand its business with various product developments. The company became privately owned last month.
In the interim, shares of Pfizer fell 7 cents to $24.55 in morning trading.