Teva receives tentative approval for generic Sensipar
JERUSALEM The Food and Drug Administration has granted tentative approval to Teva Pharmaceutical Industries’ generic version of an Amgen drug, Teva said Friday.
The FDA gave the tentative approval to cincacalcet hydrochloride tablets in the 30-mg, 60-mg and 90-mg strengths. The drug is a generic version of Amgen’s Sensipar, which has annual sales of $458 million, according to IMS Health. The drug is used to treat secondary hyperparathyroidism in patients with chronic kidney disease on dialysis.
Tentative approval means that the drug meets most of the conditions for approval, but the FDA cannot grant final approval because the patents covering the drug don’t expire until December 2016, according to FDA records. Teva and Amgen are currently involved in patent litigation concerning the drug in the U.S. District Court for the District of Delaware, though a trial has not been set, Teva said.
Walgreens puts hold on its plan to sell genetic test kits in stores
DEERFIELD, Ill. Apparently having second thoughts on a deal that would have put genetic testing kits up for sale in its stores, Walgreens said Thursday it would delay any move to offer the products until questions posed by the Food and Drug Administration about the product are resolved.
Those questions arose following published reports that Pathway Genomics would begin selling its genetic test kits in most Walgreens stores this week. The reports triggered new scrutiny from the FDA, which indicated this week that it has no record of having approved the kits for sale.
The federal agency – which may be adopting a more assertive stance to product reviews and approvals under commissioner Margaret Hamburg – told Reuters news service that it would “take a hard look at any claims made by the company.”
Both Walgreens and Pathway asserted earlier this week that FDA approval is not needed for the sale of test kits in a retail setting. But FDA spokesperson Erica Jefferson told Reuters on Tuesday, “If a company is making claims about a product that hasn’t been reviewed or validated by FDA, we want to make sure the information to consumers is accurate and the test will do what it says it will do.”
In response, Walgreens reversed course. The company said Thursday has shelved, for now, its plan to go ahead with a rapid rollout of the kits.
“In light of the FDA contacting Pathway Genomics about its genetic test kit and anticipated ongoing discussions between the two parties, we’ve elected not to move forward with offering the Pathway product to our customers until we have further clarity on this matter,” said Walgreens spokesman Jim Cohn.
The tests are saliva-based, and are intended to assess via DNA analysis patients’ genetic markers for such potential conditions as diabetes and cancer.
Mayo Clinic Health Manager seeks to organize personal medical information
REDMOND, Wash. Managing a health condition can be difficult enough, but organizing personal medical information can be even more time-consuming, according to a study commissioned by the Mayo Clinic and Microsoft, which operates the online resource HealthVault. The two have developed the Mayo Clinic Health Manager, a HealthVault application that helps people organize health information.
The study was the result of a survey of 1,065 adults conducted by Opinion Research Corp. in April. Nearly one-third of respondents said they spent more time keeping information organized than finding answers to health questions or dealing with chronic conditions.
At the same time, almost half said they regularly left doctor’s offices without asking an important medical question or giving the physician crucial information affecting their health, while 9-in-10 had reported doing so in the past.