Watson submits application to FDA for generic Fentora
CORONA, Calif. Watson Laboratories has submitted an application with the Food and Drug Administration to market a generic version of Cephalon’s cancer pain drug Fentora.
In its application, Watson asserts the ‘604 and ‘590 patents for Fentora (fentanyl buccal tablet) are invalid, unenforceable or will not be infringed by the manufacture, use or sale of the product. Both patents expire in 2019.
Cephalon has a three-year period of marketing exclusivity for Fentora that extends until September 2009. The company said it will review Watson’s notice and has 45 days to file a patent infringement lawsuit.
According to Cephalon, Fentora had sales in 2007 of over $135 million in the U.S.
Amgen, Wyeth revise labeling for Enbrel
PHILADELPHIA and THOUSAND OAKS, Calif. Amgen and Wyeth Pharmaceuticals have informed health care professionals of revisions to prescribing information for their rheumatoid arthritis and psoriasis medication Enbrel.
The revisions include a boxed warning about infections, including serious infections leading to hospitalization or death that have been observed in patients treated with Enbrel.
Infections have included bacterial sepsis and tuberculosis. The adverse reactions section of the label was updated to include information regarding global clinical studies and the rate of occurrence of tuberculosis in patients treated with Enbrel.
FDA approves Advair for wider use with COPD patients
WASHINGTON The Food and Drug Administration has approved GlaxoSmithKline’s asthma drug Advair to be used more widely to treat patients with chronic obstructive pulmonary disease, according to published reports. The drug had been approved to prevent wheezing and control other symptoms in COPD patients.
GSK’s approval comes the same day as rival AstraZeneca said it also was seeking FDA approval to sell its drug Symbicort for COPD.
COPD, an often-fatal lung condition with no cure, is a major market with more than 12 million Americans suffering from the disease, and another 12 million who are likely not diagnosed, according to the National Institutes of Health.
The FDA’s approval allows GSK to promote its product to COPD patients who experience flare-ups of the disease, which includes emphysema and chronic bronchitis.