FDA tentatively approves Perrigo’s generic HalfLytely, bisacodyl tablets bowel prep kit
ALLEGAN, Mich. The Food and Drug Administration has granted tentative approval to Perrigo’s generic version of a set of drugs used prior to colonoscopies, Perrigo said Wednesday.
PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution and bisacodyl delayed-release tablets is a generic version of Braintree Labs’ HalfLytely and bisacodyl tablets bowel prep kit. Perrigo acquired the rights to the regulatory approval application for the generic version from Novel Labs, and the FDA granted the tentative approval on Thursday.
Atentative approval means that a generic drug meets the FDA’s conditions for approval, but can’t be marketed until the patents covering the branded version have expired.
Teva launches generic Yaz
JERUSALEM Teva Pharmaceutical Industries has launched a generic oral contraceptive, the drug maker said Tuesday.
Gianvi is the generic version of Bayer’s Yaz tablets, which had total sales of nearly $782 million in the United States for 12 months ended Dec. 31. Teva has been awarded a 180-day period of marketing exclusivity for the contraceptive.
As previously announced, Teva has the right to launch an authorized generic version of the product, supplied by Bayer, in July 2011.
Consumer Reports survey: Antidepressant use on the rise
YONKERS, N.Y. A new Consumer Reports health survey found that nearly 80% of respondents seeking treatment for depression or anxiety were prescribed antidepressants.
Of the 1,500 subscribers surveyed, Consumer Reports found that 78% respondents use antidepressants to aid their mental health issues. CR also found that 58% had experienced anxiety, up from 41% in 2004 when CR last surveyed subscribers about these conditions. The survey sought to show how subscribers treat their mental health conditions and asked readers who took drugs for anxiety, depression or both within the past three years to rate them.
The survey also found that older, often less expensive antidepressants known as SSRIs (selective serotonin reuptake inhibitors) such as Lexapro, Celexa, Prozac and Zoloft work just as well, and with fewer side effects (51% of respondents said), than newer, more costly drugs known as SNRIs (serotonin and norepinephrine reuptake inhibitors) like Cymbalta and Effexor (49%). SSRIs and SNRIs address depression by altering the levels of certain brain chemicals, CR said.
CR also found, however, that talk therapy was effective in treating anxiety or depression in patients, it received high marks from CR’s survey participants–91% said therapy made things “a lot” or “somewhat” better. People who stuck with talk therapy for at least seven sessions had significantly better outcomes that those who went to six or fewer sessions. What’s more, they scored as high as people treated mostly with medication on an overall outcome scale.
“Pharmaceutical companies stand to profit most from convincing consumers that drugs are the only answer to depression and anxiety, and that newer, more expensive drugs are a better alternative to older drugs and their generic counterparts,” said Nancy Metcalf, senior program editor, Consumer Reports Health. “Our survey shows that a combination of therapy and medication works best, and that despite the intense marketing push consumers are subjected to, there is no evidence that newer drugs like Pristiq and Cymbalta work any better than older medications in their class.”
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