Fda approval of generic cymbalta
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How much does generic cymbalta cost ?", "Is the generic version of cymbalta more effective than the brand name version, and if so, how much more effective is the generic version?", and "What should you do if your doctor tells you the generic version of cymbalta has a shorter duration of action than the brand name version of cymbalta?" In response, FDA received a total of 1,664 questions and 3,100 comments. Nearly 90 percent of the comments and 90 percent of the questions were addressed by FDA in its response (the questions and comments can be found at www.regulations.gov/2012/5761). The comments received by FDA were more than 90 percent similar to the comments received by HHS from an anonymous online survey: namely, the comments and questions about efficacy of pharmaceutical products were similar, but FDA received significantly fewer comments from the pharma industry that provided information regarding drug development costs, the use of patents and trade secrets, costs of clinical trials, the use drug development in developing countries, the price paid by pharmaceutical companies for generic versions of drug products, and the use of generic drugs by the uninsured. In addition, FDA received virtually identical comments and questions about whether generic drugs should be approved for the same indications as branded drugs, and whether generic drugs should be exempt from labeling requirements for marketed brand name drugs if they are otherwise equivalent. In response to the concerns raised through public and congressional comments, FDA proposed to make two changes. First, FDA proposed to specify that "generic drugs otherwise would be subject to the same label provisions if an investigational new drug application is filed could be subject to substantially the same conditions only if it is determined that the generic drug is interchangeable with the branded drug for such indication" (58 FR 11881). Second, FDA proposed to make some amendments in its proposed regulation. However, FDA to retain all relevant provisions in its proposed regulation. The comments received from FDA indicated that its proposed amendment would result in significant reductions the prices of generic drugs to those patients who need and can afford them, the commenters suggested that many such individuals may not be aware that generic drugs were being brought to market (see e.g., FDA's preamble to the proposed rule (59 FR 48837), and a letter to the Committee from Pharmaceutical Manufacturers of America, the American Pharmaceutical Association, Research and Manufacturers of America, the American Association for Advancement of Science, and the Academy Pharmaceutical Sciences). FDA has filed an initial rulemaking under section 505(b)(8) of the Act (60 FR 703) proposing a number of modifications in the prior rule. For example, FDA proposed to prohibit a pharmacist from selling generic version of a branded drug for which final approval has been granted for a limited indication or uses for which the manufacturer has filed a label amendment or labeling claim. In addition, FDA proposed on October 26, 2011, to clarify that the Secretary must review clinical trial and postapproval data on generic drugs in the same manner that Secretary reviews the clinical trial and postapproval data for the branded drug in which that has been withdrawn from the market and to add certain additional provisions the criteria that may be used to determine a new or amended indication. For additional background on FDA's proposed change, see the October 30, 2011 preamble to the proposed regulation (61 FR 27123), and on January 31, 2012, FDA posted a notice announcing that it would make the proposed rulemaking changes public as a final rule on April 26, 2012. This notice, which summarizes the comments received from public, industry, and other stakeholders, provides an opportunity for interested parties to comment in response the proposed changes to a specific issue, such as the availability of original labeling, data supporting the claim regarding effectiveness of generic drug in the patient population, and availability of research supporting the original labeling. To facilitate the review of comments received, FDA has decided to make the proposal and proposed rulemaking changes publicly available online as a final rule on its website. Commenters will have 30 days to submit written comments regarding the public release of proposed rule. These comments will be reviewed by FDA to determine if any changes the proposed rule are warranted by the comments received and, if necessary, will be posted for the commenters to make further comment. information regarding the issuance of a final rule can be found in the Federal Register Notice Cymbalta 60 Pills 30mg $179 - $2.98 Per pill announcing issuance of the (62 FR 14291), and Federal Register Notice announcing the of proposed rulemaking change (63 FR 91235). Additional information can be found in the proposed rulemaking guidance. In this policy release, FDA has made a series of significant changes to the proposed rule that will reduce the costs of generic drugs to the patients who need and can afford them. As a result of these changes, FDA proposes to: Adopt a simplified regulatory scheme for reviewing and approving generic drug applications.
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Cymbalta is an antidepressant. It is used to treat depression. It is also used to treat pain caused by complications of diabetes or pain caused by fibromyalgia.
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Generic cymbalta available us d Cymbalta comes in tablets or capsules and is commonly prescribed to treat depression. You can also buy it as cymbalta generic fda approval a liquid, which can be taken orally. Cymbalta isn't for all types of depression and the way it works is still unclear. What Cymbalta isn't Cymbalta hasn't been found to be a safe or effective treatment for most types of depression. Cymbalta isn't for everyone and it children. You can fall into the trap of thinking you have to take Cymbalta if you have depression, but it isn't the best treatment for most people. If you're worried about a loved one, talk to them first. Do you get some of Cymbalta's side effects? You can develop a number of rare cymbalta side effects. We try to notify patients about these side effects as soon they are known. Common Cymbalta side effects Common side effects of Cymbalta include: Itching, burning, nausea, vomiting and severe headaches. These can occur in up to 10 percent of people with depression. These side effects generic cymbalta actavis are usually temporary and go away when you stop taking Cymbalta. These side effects are usually temporary and go away when you stop taking Cymbalta. Dry mouth (drying of the mouth), which can happen after Cymbalta. Some people develop drowsiness, dizziness or lightheadedness after taking Cymbalta. These changes usually go away after a few weeks of treatment. These changes usually go away after a few weeks of treatment. Decreased appetite, appetite can lead to weight loss and gain. In rare cases, Cymbalta can cause a serious heart condition called torsade de pointes (TDP), which is very dangerous. Your heartbeat can slow or stop completely. This can cause a sudden and serious fall in blood pressure and heart rate, a stroke or even heart attack. Tell your doctor if you have other heart problems or are overweight. Commonly reported side effects of Cymbalta include: Headache Nausea, vomiting and diarrhea Anxiety Depression Elevated blood pressure Headache and dizziness Sore throat, cough and fever Slight stinging of the lips The most common side effects of Cymbalta that you should talk to your doctor about are listed here: Flu-like symptoms Diarrhea, pain, and cramping in the stomach or lower abdomen Heartburn Itching, burning and itching at the injection site Nausea, vomiting and other symptoms that are like the flu Sore throat, itching, throat pain, and fever Rarely reported side effects of Cymbalta Cymbalta can cause a rare, serious heart condition called Torsade de pointes (TDP). This is extremely serious and some patients have died as a result of TDP. If you develop TDP, may have: Extremely slow or irregular heartbeat A sudden and serious fall in blood pressure and heart rate A stroke or heart attack Treatment of Cymbalta Treatment for depression usually involves a combination of psychotherapy and medication. Psychotherapy Psychotherapy is the most common type of treatment for treating depression. It can include talking therapies and cognitive behavioral therapy (CBT). teaches you how to change your thoughts and behavior. Cognitive behavioral therapy often uses medication to help you quit using the drugs. The type of psychotherapy you use depends on the type of depression you have. Talk therapy. therapy is often the first, most effective treatment for depression. Therapists work with you to create a plan get better. They learn about how your brain works and it's affected by depression. You work with your therapist to build a treatment plan help you stop using antidepressants and to start taking them less often. Talk therapy can involve a number of different types therapy and you should talk to your doctor or a therapist about what is right for you. Treatment is usually continued for several weeks or months until you start getting better. If are depressed and using antidepressants, talk with your doctor about getting the drugs off of your medicine or getting a new antidepressant. Psychotherapy isn't for everyone. Talk to your doctor about whether you can start treatment or whether you should get therapy for depression. CBT. CBT is a type of psychological therapy that uses talking, reasoning and relaxation techniques. CBT can be done individually or in groups and can involve several people. You talk about your problems with friends and family before you start CBT.
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