Teva launches its generic version of Famvir, announces its availability
NEW YORK After hearing that the U.S. Court of Appeals for the Federal Circuit denied the emergency motion filed by Novartis regarding its Famvir medication, Teva has begun launching its generic version, Famciclovir tablets in 125, 250, and 500 mgs.
Novartis following a U.S. District Court in New Jersey’s preliminary injunction in favor of Teva filed the emergency motion to block sales of the drug. While Novartis appeals this decision, the Court of Appeals has decided to allow Teva to manufacture a generic, by refusing to order a sales halt while Novartis appeals the decision. The drug is used for the treatment of shingles and genital herpes.
Famvir had sales of $200 million for the 12 months ending June 30, 2007.
FDA increases potency of levothyroxine products
WASHINGTON The Food and Drug Administration is strengthening the potency specifications for levothyroxine sodium to ensure the drug retains its potency over its entire shelf life.
The agency is increasing the specifications from a 90 to 110 percent potency range to a 95 to 105 percent range. The percent ranges were changed following concerns about the product by healthcare professionals and patients.
Data taken by the FDA showed that some of the levothyroxine products like blister packs degrade quicker than other package types. Also, some of the strengths have been shown to degrade more rapidly than others.
Manufacturers and marketers have two years to comply with the revised specification. Levothyroxine sodium products are used by over 13 million patients.
FDA to review heart problems from osteoporosis drugs
WASHINGTON The Food and Drug Administration is looking at new safety data on reports of atrial fibrillation in patients taking bisphosphonates.
Bisphosphonates are used to treat osteoporosis. The FDA is looking into the issue after a study in the May 3rd issue of the New England Journal of Medicine reported increased rates of serious atrial fibrillation in patients taking Fosamax and Reclast.
The FDA has performed an initial review and found that there was not a large enough group of people who were at risk for atrial fibrillation and would not as of right now ask for healthcare professionals to change their prescribing habits or to tell patients to change their use of the drugs.
The agency is seeking additional data to perform an in-depth review of the issue that could take up to one year to conclude.