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Teva filgrastim fda

Common Questions and Answers about Teva filgrastim fda

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572651 tn?1530999357 //www.businessweek.com/news/2013-01-10/teva-cites-bg-12-safety-in-asking-fda-to-add-ms-reviews Make of it what you will....
667078 tn?1316000935 Mylan a big maker of generics like Teva has teamed up with Natco an Indian Pharmaceutical, who makes a generic of Copaxone. They have been fighting with Teva in U.S. Courts over patent infringement for years. PITTSBURGH, Sept. 14 /PRNewswire-FirstCall/ -- Mylan Inc. (NASDAQ: MYL) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing Mylan Pharmaceutical Inc.
Avatar f tn The Bristol-Myers Squibb ($BMY) hepatitis B drug saw its composition of matter patent invalidated in a court fight with Teva Pharmaceutical Industries ($TEVA), which wants to sell its own version. The patent had been due to expire in 2015. It's unclear whether the ruling will expose Baraclude to immediate generic competition.
Avatar f tn i am really responding to sean as i was given some very helpful information as i was on the green generic TEva klonopins 1mg for years and they just switched to actavis yellow pharmacist telling me its all about the cost.
Avatar m tn s Baraclude treatment for hepatitis B after a challenge from generic drugmaker Teva Pharmaceutical Industries Ltd, Bristol-Myers said on Tuesday. "We are disappointed with the court's decision and believe it is incorrect," Bristol-Myers spokeswoman Laura Hortas said. She said the company is considering whether to appeal the ruling by the U.S. District Court in Delaware.
Avatar f tn The latest I heard was that Teva has petitioned the FDA to require new phase 2 and pahse 3 studies for the Copaxone generics "since the process and formulation of the generics hsa not been proven to be as safe or as clinically effective as the Teva formulation." There is a several million dollar hit ot getting a generic to market. "Teva is pulling out all the stops to protect Copaxone, which provides 25%-33% of the pharmaceutical company's profit.
Avatar f tn Another company has a generic of Copaxone and is fighting in the U.S. courts with Teva. Ironically Teva fights in court to make generics of all the other best selling drugs in the U.S. Teva's marketing is expensive as is the whole Share Solutions organization which is to get and keep as many MS patients on Copaxone and to find out about problems with the drug before the FDA does.
Avatar n tn Filgrastim is also prescribed as pegfilgrastim (called Neulasta). My doctor used the 500 neutrophill count as a cut-off, so every time I got down around 500 I used Neulasta. The interferon drops neutrophils and platelets. Some people can do okay with low neutrophils but just as many end up with kidney and sinus infections, etc., that make you even more miserable.
Avatar f tn Companies that want to add to or change anything about a previous FDA approval must resubmit for a new approval and relabeling. That is why TEVA had to go through a new process to change Copaxone dosing from 20mg daily to 40mg three times a week. It's the same thing as happens when a drug is FDA approved and released to treat Thing One and is later found to be good for treating Thing Two. It's used "off-label" for Thing Two.
Avatar m tn According to the linked story, "An FDA advisory panel has until March 28 to decide whether BG-12 meets safety standards that would permit the drug to hit the market." So I would figure the drug is still at least three months from market. http://www.haaretz.com/business/teva-scrambles-to-block-approval-for-biogen-s-copaxone-rival-1.
Avatar n tn I have read a number of blogs including this one that indicate that hair loss is a side effect yet the Wellbutrin trials only listed hair loss as a side effect for less than 1% of patients. Given the U.S.
493068 tn?1224765315 my stats seem to go up and down so I only have to take it now every 2 wks. It is unknown whether filgrastim (Neupogen) increases or decreasses an individual's risk of developing cancer. Based on limited long-term data from healthy people ( if a person is healthy why would they need neupogen in the first place ) who have received filgrastim, no long-term risks have been found so far. good luck to you....hope this helped!
Avatar n tn Hi, my mom was taking teva-rabeprazole 20mg and now she is out of them can she take pantoprazole 40mg now?
476246 tn?1418870914 , the primary ‘rescue’ meds are (generic) epoetin alpha (brand names Epogen, Procrit, Aransp), and filgrastim (generic) (brand name Neupogen). We do have a platelet booster here that has been approved for cancer treatment; it is generically known as oprelvekin (brand name Neumega), but its use has not been FDA approved for HCV treatment to my knowledge; it tends to worsen hemolytic anemia, although we have had a few patients in forum that have tried it.
Avatar m tn Do you mean filgrastim? And are you saying Dengue fever? It would be a surprising though perhaps not impossible use of filgrastim. Dengue is usually treated by pain managers and sometimes hospitalization and a blood transfusion. Anyway, if you have a legitimate prescription from a doctor, you should be able to fill it in the United States.
Avatar n tn I have put them through the ringer about generic vs brand and every single one of them has assured me that the main chemical compound of any and every generic medication made in the USA must meet the EXACT same FDA approved chemical compound of the brand name. The ONLY thing that can be different is the "fillers." The fillers do not alter the strength or efficacy of the medication at all.
4478309 tn?1356061667 speaking fees, Bayer Schering Pharma, Biogen-Dompé AG, Genmab A/S, Merck Serono, Teva Pharmaceutical Industries Ltd; travel expenses, Teva, Biogen-Dompé AG, Merck-Serono, Sanofi-Aventis, Genmab, Bayer Schering. K.F.
Avatar f tn For this reason, patients are prescribed antibiotics and even receive injections to increase white blood counts (such as filgrastim or lenograstim). If this 0.4 value really pertains to your white counts, then I believe this is really low and what you are experiencing is a condition called 'febrile neutropenia'. I would suggest you ask your doctor about filgrastim or lenograstim injections aside from the Levaquin. Regards.
Avatar n tn also i am now taking brand name klonopin instead of teva and can tell its more powerful. .5 mg of klonopin is noticeably stronger than .5 of teva clonazapam. so i am hoping that the .5 bid is just as good or better than the weaker teva at .25 qid. i greatly appreciate your knowledge and willingness to help others.
572651 tn?1530999357 Hi everyone, I mentioned in a thread with Julie, that Copaxone has been approved by the FDA to use in people with Clinically Isolated Syndrome. She was very interested and I posted the links there. But in case you don't see that post, I thought it would be good to start a new discussion here. This news was released by TEVA, the mfg. of Copaxone, in early March. http://www.medicalnewstoday.com/articles/141213.
585414 tn?1288941302 http://www.dailyfinance.com/story/drug-shortages-a-deadly-problem-with-no-cure-in-sight/19783927/ "Drug Shortages: A Deadly Problem with No Cure in Sight" By MELLY ALAZRAKI If gasoline or jobs or milk were in short supply, we'd all know about it. But unknown to most Americans, the country is now in the grips of a life-threatening drug shortage. Medical professionals are quite aware of it, however, and they're deeply concerned. So is the Food and Drug Administration.
Avatar f tn I have recently started the patch and have found a difference between effectiveness of the two brands TEVA and MYLAN. First I had Teva 12mcg/72hrs (twice) then 2X 12mcg/72 (twice) and then went to 50mcg patches on the 72hr interval, so far twice. The 25mcg patches are Mylan brand and I noticed, pretty quickly, a decrease in effectiveness. Has anyone else? My pharmacy says I can specify... otherwise the script will be filled with Mylan.
572651 tn?1530999357 The NMSS has posted a link to the FDA recall website - Triad Alcohol Prep Pads, Swabs and other assorted items for prepping before injections have been recalled. I just checked and these are the wipes I get with my Copaxone. I'm not sure what the other injectibles send for site prep. It is unclear if this applies to the ones supplied to me, but if the NMSS felt it necessary to post this warning, it is worth sharing with you.