FDA approves new labeling for Janumet
WHITEHOUSE STATION, N.J. The Food and Drug Administration has approved expanded labeling for Merck’s type 2 diabetes drug Janumet.
According to the agency, the new regimens for Janumet in the updated labeling include: 1) initial therapy in patients inadequately controlled with diet and exercise alone and 2) add-on therapy to a sulfonylurea, (examples: glipizide and glimepiride), when the combination of a sulfonylurea and metformin does not provide adequate glycemic control.
Janumet, according to Merck, achieved worldwide sales of $44 million during the fourth quarter of 2007, and reported $86 million in global sales for the year.
Combo vaccine for kids linked to fever and seizures
ATLANTA A study by the Centers for Disease Control and Prevention has shown that children suffered higher rates of fever-related convulsions when they got a Merck combination vaccine instead of two separate shots, according to published reports.
Prior to the findings, the CDC’s Advisory Committee on Immunization Practices had stated a distinct preference for the ProQuad vaccine, which protects against measles, mumps and rubella as well as chickenpox. The committee’s argument was that it would be better to give children the fewest injections possible.
Now, however, the committee has withdrawn its preference for ProQuad, choosing not to exhibit any preference at all. “Safety, shortages, delivery issues—lots of reasons not to state such a strong preference,” said a committee member. ProQuad costs $124 per dose, about the same as the two other shots combined.
In the study of children ages 12 months through 23 months, the rate of seizures was twice as high in toddlers who got ProQuad, compared with those who got one shot for chickenpox and one for the three other diseases. Neither the convulsions, nor the fevers that engendered them resulted in any child deaths. Merck has conducted its own study with similar results: 1 occurrence in approximately 2,000 children.
Procter & Gamble wins patent suit for Actonel
CINCINNATI The United States District Court of Delaware today ruled in favor of the Procter & Gamble Company in the patent infringement lawsuit filed by P&G against Teva Pharmaceuticals. The positive ruling protects P&G’s rights in the U.S. to exclusively market the osteoporosis therapy Actonel (risedronate sodium tablets).
P&G filed a patent infringement lawsuit in August against Teva to enforce P&G’s U.S. composition of matter patent for risedronate, the active ingredient in Actonel. Teva was seeking to market a generic version of Actonel in the United States under the assertion that the Actonel patent was not valid due to obviousness of the invention.
The court ruled today in favor of the patent. “We are pleased that the Court recognized and acknowledged the uniqueness of the risedronate molecule,” said Tom Finn, P&G president of global health care. “We are very proud of the extensive R&D efforts which brought Actonel to market, providing patients help that they need to manage their osteoporosis and prevent fractures.”