Generic Migraine Medication Approved by FDA

FDA Approves First Generic Divalproex Sodium to Treat Seizures, Migraine Headaches and Bipolar Disorder

The U.S. Food and Drug Administration today approved the first generic versions of Depakote delayed-release tablets (divalproex sodium). Depakote is approved by the FDA for the treatment of seizures, bipolar disorder and migraine headaches.



"Generic drugs undergo a rigorous scientific review to ensure that they will provide the patient with the same amount of high quality, safe and effective drug as the name brand product," said Gary J. Buehler, director of the FDA's Office of Generic Drugs. "This approval provides an additional treatment option for patients who suffer from epilepsy, bipolar disorder and migraines."



Generic divalproex sodium will have the same safety warnings as Depakote, including a Boxed Warning that cautions about the risk of liver damage (hepatotoxicity), including fatalities, and pancreatitis, or an inflamed pancreas, including fatal cases. The Boxed Warning also highlights the risk of birth defects (teratogenicity), including neural tube defects.



The following firms have received approval to market divalproex sodium delayed-release tablets: Sun Pharmaceutical Industries Ltd., Mumbai, India; Genpharm Inc., Ontario, Canada; Nu-Pharm Inc., Ontario, Canada; Upsher-Smith Laboratories, Maple Grove, Minn.; Sandoz Inc., Broomfield, Colo.; TEVA Pharmaceuticals USA, North Wales, Penn.; Dr. Reddy’s Laboratories, Hyderabad, India; and Lupin Limited, Mumbai, India.



For more information, see

Consumer Education: Generic Drugs



Information on specific drug products can be found on the Web site "Drugs@FDA"

http://www.accessdata.fda.gov/scripts/cder/drugsatfda/



This is the complete article. Unless otherwise noted, the contents of the FDA Website (www.fda.gov)--both text and graphics--are not copyrighted.

Migraine Medication Savings

As I said in my last post something good has come out of obnoxious pharmaceutical television commercials and radio advertisements - COUPONS, REBATES, VOUCHERS and FREE MEDICATION TRIALS. Listed below are current savings on medications that Migraine sufferers often use. There are different qualifications for each medication offer. Please make sure you read the FAQ's and/or patient eligibility guidelines carefully to see if you qualify.



Savings offers on the following drugs are below:

Treximet, Zomig, Maxalt, Migranal, Frova, Relpax, Topamax, Cymbalta, Kadian, Ambien, Lunesta, Ultram ER, Duragesic, Soma, Skelaxin

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Treximet® - Lower The Pain



Receive your $50* coupon by filling out the brief form below, then clicking “Submit.” We'll also provide you with important news and information about migraine treatment, as well as additional valuable money-saving offers for TREXIMET. Only one $50 trial coupon per person.

source: https://www.treximet.com/optin/registration.jsp



In order to be eligible for this offer: (a) where third-party reimbursement covers a portion of your prescription, this coupon is valid only for the amount of your actual out-of-pocket expenses up to a maximum of $50, (b) your prescription MUST NOT be covered (i.e., reimbursed) by a federal healthcare program, including Medicare or Medicaid, or by any similar federal or state program, including a state pharmaceutical assistance program, and (c) you MUST NOT be Medicare eligible and enrolled in an employer-sponsored health plan or prescription drug benefit program for retirees (i.e., you are eligible for Medicare Part D but receive a prescription drug benefit through a former employer). Further, if you are a resident of Massachusetts, this offer is valid only if you are paying the entire cost of the prescription yourself (i.e., your insurance does not cover any of the cost of your prescription). Your acceptance of this offer must be consistent with the terms of any drug benefit provided by your health insurer, health plan, or private third-party payor, and you agree to report acceptance of this offer to your health insurer, health plan, or third-party payor as may be required. This offer may not be used with any other discount, coupon, or offer. Only an original coupon will be accepted and must be presented to your pharmacist at the time you have the prescription filled–not valid if reproduced. Offer good only in USA. Not transferable. Void where prohibited by law, taxed, or restricted. GlaxoSmithKline reserves the right to rescind, revoke, or amend this coupon without notice. Limit 1 per purchase. Only one $50 trial coupon per person.

source: https://www.treximet.com/optin/registration.jsp#

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Zomig® - Living With Migraine Voucher Program

Welcome to the Zomig Cost-Saving Coupon Program. This coupon may cover payment for your co-pay for a ZOMIG prescription up to $35, for up to a maximum of 6 times in 12 consecutive months. If you are not enrolled in a pharmacy benefits program, you may receive $35 off your ZOMIG prescription purchase or the amount paid for your prescription, whichever is less, for a maximum of 6 times in 12 consecutive months. Please see enrollment requirements and other terms and conditions.

source: https://www.activatethecard.com/zomig/appSecZomigWelcome.jsp

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Maxalt® - Free Trial Offer

Merck is pleased to provide a free trial offer of MAXALT or MAXALT-MLT. To receive your voucher for a free trial of up to 3 tablets or 3 orally disintegrating tablets, click on the PRINT VOUCHER FOR A FREE TRIAL button at the bottom of this page and print out the voucher form.



If MAXALT / MAXALT MLT is the appropriate therapy for you, your doctor will write a prescription for you. Then take your prescription and the voucher to your pharmacist to get your free trial of up to 3 tablets or 3 orally disintegrating tablets. This offer is valid only with a prescription from your doctor. Offer expires 12/31/2008.



Limitations apply. Please see Terms and Conditions on the voucher for details.

source: http://www.maxalt.com/rizatriptan_benzoate/maxalt/consumer/special_offers/free.jsp?WT.svl=5

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Relpax® - Step Up to the Challenge and Get a $10 RELPAX Coupon

To qualify for the rewards program, you must be taking RELPAX. If you are not currently a RELPAX user, ask your doctor if RELPAX is right for you and enroll once you’ve tried it.

source: https://www.relpaxchallenge.com/content/coupon-registration.jsp

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Migranal® - It's Never Too Late for Relief

Let MIGRANAL^® help you gain control of your migraines.

Do you wait until your migraine is already at full strength before taking your medication?



Do you “hoard” your medication and only use it when the pain becomes unbearable?

$20 off your next prescription of MIGRANAL

source: http://prescriptionmigrainerelief.com/HTML-INF/4_0_Try_Migranal_Today/index.shtml

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Frova® - Rebate save up to $35

Offer expires 12/31/08

source: http://www.frova.com/dtp/_pdf/FROVA_Rebate_Voucher.pdf

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Topamax® - Free Trial Offer for up to 42 (25mg) tablets

1. Talk to your doctor to find out if TOPAMAX is right for you. TOPAMAX is available by prescription only.


2. If your doctor prescribes TOPAMAX, you can get up to 42 TOPAMAX 25 mg tablets free from your pharmacist with this offer.


3. Present your written prescription for up to 42 TOPAMAX 25 mg tablets AND this trial offer to your pharmacist to receive your free trial of TOPAMAX.

source: http://www.topamax.com/topamax/tools-resources--free-trial-offer.html

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Cymbalta® - This voucher is valid for 14 Capsules of CYMBALTA (all strengths covered) and must be accompanied by a valid prescription.

Thank you for your interest in a free sample of Cymbalta® (duloxetine HCl). Remember, only your doctor or healthcare professional can diagnose your condition and determine proper treatment.



To receive your free voucher, please enter your age and select your indication below, then click "Submit." When the voucher page appears, be sure to follow all instructions listed. Because there is a 1-voucher limit per person, you will not be able to return to the voucher page once you have left it. Please print the voucher page before leaving it. If you have difficulty, please call 1-800-LillyRx (1-800-545-5957).

source: http://voucher.cymbalta.com/

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Kadian® - Save up to $50 on each KADIAN® monthly prescription

To receive a co-pay assistance card in the mail for up to $50 off each KADIAN^® monthly prescription, please provide the following information or call 1-877-265-2861

source: http://www.kadian.com/pages/getpage.aspx?id=4F94959E-FE71-4158-9276-83A0FF8F20102010

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Ambien CR® - Try our free 7-night invite and get up to $100 off when you join

If you're having trouble sleeping and think you could be experiencing insomnia, you've come to the right place. Two layer AMBIEN CR not only helps you fall asleep, but has a second layer to help you stay asleep*, so you wake up less frequently and fall back to sleep faster. And now we have two offers to make it easy for you to try AMBIEN CR and save on your prescription.

To get your offers:

• Click on GET CERTIFICATES


• Print your certificates and take them to your healthcare provider


• If your provider thinks AMBIEN CR is right for you, take your AMBIEN CR prescription and certificate to your pharmacist for your FREE trial offer


• Start experiencing the 2-layer difference of AMBIEN CR

You can also continue to save up to $20^† on each of your next 5 AMBIEN CR prescriptions—that's up to $100 in savings!



Start making a difference in your life today.

* Proven effective for up to 7 hours in clinical studies.

^† Maximum benefit is $20 off, on up to 5 prescriptions, depending on your out-of-pocket costs. Not valid for patients participating in Medicare, Medicaid, government (public insurance) programs, or any private payor in the state of Massachusetts and where prohibited by law.

source: http://www.ambiencr.com/cr-extras/ambien-coupon-free-trial.aspx

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Lunesta® - SIGN UP FOR 7 NIGHTS OF LUNESTA FREE AND FOR SPECIAL LUNESTA OFFERS AND UPDATES.

Are you ready to find out whether or not LUNESTA is right for you? We're ready to help you do just that with this special offer. Getting a good value is as nice as getting a good night's sleep.

Try LUNESTA for 7 Nights Free.

As with all medications, individual results vary, so the only way to find out if LUNESTA works for you is to give it a try. Talk to your doctor about your symptoms and about LUNESTA. If you and your doctor decide that LUNESTA is right for you, use this coupon for 7 free nights of LUNESTA.



Follow these simple steps to take advantage of this free trial offer:

STEP 1: Complete the form below.

STEP 2: Click the Submit button to display the Trial Script® Coupon.

STEP 3: Click the Print button located at the bottom of the Trial Script ® Coupon, bring it to your doctor and ask if LUNESTA is right for you.

STEP 4: After your doctor attaches the coupon to a completed, signed prescription form, go to your pharmacist and receive your free tablets of LUNESTA

Source: https://secure.lunesta.com/lunestaPromos/lunesta-coupon.cfm

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Ultram ER® - Free Trial offer or up to 2 weeks free

Get more information - and up to 2 weeks of ULTRAM® ER, free

or

Special offer if you are already taking ULTRAM® ER -- Save $25 on your ULTRAM® ER prescription and up to two refills.

source: http://www.ultram-er.com/ultram-er/age_check.do?coupontype=voucher&source=Web

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Duragesic® - Instant Savings up to $50

Please be advised that we will not collect any of your personal information when you generate the savings coupon for DURAGESIC^®. To learn more about the information collection practices for this savings coupon, please refer to the DURAGESIC^® Coupon Privacy Policy. The information found within the DURAGESIC^® Coupon Privacy Policy applies only to this savings coupon and differs from the general Privacy Policy for www.DURAGESIC.com.

source: http://www.duragesic.com/duragesic/exit_coupon.html?&newURL=http://69.20.85.102

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Soma® 250mg - Instant Savings Up to $30 off your SOMA® 250 mg prescription

1. Fill out the form below

2. Print out your money saving coupon

3. Presenting the coupon to your pharmacist along with your insurance card and a valid prescription for SOMA® 250 mg

coupon expires 12/31/2008

source: https://www.drtms.net/Acquire/Acquire.aspx?client=MPTSoma&product=Loyalty+Card&grpnum=OH5101031&c=24&p=W1&s=1&action=print

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Skelaxin® - Good for up to $30 off 1 prescription

SKELAXIN 800MG (metaxalone) Tablets Prescription Savings Coupon

If your healthcare professional decides that SKELAXIN^® is right for you, you can take advantage of this special offer to save up to $30 on your next prescription for SKELAXIN^®. Simply download and print the form below, fill it out, and take it to your healthcare professional. Then take it to your pharmacist when you fill the prescription.

source: http://www.skelaxin.com/skelaxin-coupon.aspx?text=1

Pharmaceutical Ads - Give Me a Break!

I've had it up to my eyeballs with pharmaceutical advertising! If you're like me, you're probably sick of these controversial ads too. Every time we turn on the TV, we're bombarded with ads for conditions such as Migraine, Elevated Cholesterol, Depression, Peripheral Arterial Disease (PAD), Attention Deficit Hyperactivity Disorder (ADHD), and of course Erectile Dysfunction.

Do you know who Dr. Robert Jarvik is? My tweenager does. He watches enough TV to know that Dr. Jarvik is the spokesman for Pfizer's cholesterol lowering medication, Lipitor, and that he invented the artificial heart. He can also recite the words verbatim, “When diet and exercise aren’t enough, adding Lipitor significantly lowers cholesterol”. The New York Times tells us what my son and millions of other people in TV land don't know:

...though Jarvik graduated from medical school, he's not licensed to practice medicine or to write prescriptions. He doesn't see patients. He was a consultant to Lipitor maker Pfizer, under contract for $1.35 million. And he didn't start taking Lipitor until a month after he started doing the ads. Oh, and that wasn't him rowing; it was someone who looked like him in a similar jacket.

Because of these ads, my preteen can also explain what Erectile Dysfunction is, tell you about Viagra, warn you "in the rare event of an erection lasting more than 4 hours, seek immediate medical help to avoid long-term injury" and sing all the words to the "Viva Viagra" song.

Even though I'm sick of these commercials, one good thing has come out of this...COUPONS, REBATES, VOUCHERS AND FREE TRIALS. For more information on this see my next post.

Migraine/Epilepsy Drug Linked to Birth Defects

Topamax May Raise Risk of Birth Defects

Small Study Shows Increase in Birth Defects When Epilepsy/Migraine Drug Is Used During Pregnancy

The epilepsy and migraine prevention drug Topamax has been linked to an increased risk of birth defects in babies born to epilepsy patients who took it during pregnancy, a small study shows.

In a study published in the latest issue of the journal Neurology, taking Topamax (topiramate) during pregnancy was associated with a birth defect risk within the range of risk seen in other anti-epileptic drugs, researchers reported.

To read the entire article click HERE.

Abnormal Sleep Patterns in Women Linked to Stroke

NEW YORK (Reuters Health) - Sleep patterns in middle-aged women can increase their risk for stroke, researchers in the United States have found. The greatest increase in stroke risk -- 70 percent -- was noted among women who slept 9 hours or more per night, according to their report in the medical journal Stroke.

To read the entire article click HERE.

Cymbalta Approved For Fibromyalgia Treatment

Cymbalta (Duloxetine) has just been approved to treat Fibromyalgia. Until now, there was only one medication, Lyrica (Pregabalin), approved to treat this illness.

In addition to the side effects of Cymbalta, Medpage Today warns:

Duloxetine should not be taken by patients who are using or have recently used a monoamine oxidase inhibitor, patients taking thioridazine (Mellaril) or patients with uncontrolled glaucoma. Severe and sometimes fatal liver problems have been reported among patients taking duloxetine. Duloxetine may increase the risk of hemorrhage among patients taking NSAIDs, aspirin, or other blood thinners.

Cymbalta is also approved for Major Depressive Disorder, the pain caused by Diabetic Peripheral Neuropathy and Generalized Anxiety Disorder.

Migraine and Fibromyalgia are often comorbid. Other illnesses comorbid with Migraine include but are not limited to Thyroid Disease, Temporomandibular Disorders, Depression, Anxiety, Epilepsy, Hypertension, and Stroke.

The Drew Carey Project Releases Another Medical Marijuana Reason.tv Video

Although the Drug Enforcement Administration (DEA) tells us in Exposing the Myth of Smoked Medical Marijuana that there are no potential benefits of medical marijuana, many states have laws that allow those with specific debilitating medical conditions the right to use it. It is a well documented remedy for many health conditions including Migraine, Glaucoma, Multiple Sclerosis, Cancer, HIV and Aids.

However, federal legislation prohibits the use of Medical Marijuana. Since federal law supersedes state law, the DEA continues to raid and prosecute both users and distributors in the states that allow it's use.

Drew Carey, (yes, that Drew Carey) host of The Drew Carey Project. has released another Reason.tv video on medical marijuana. In this video Carey asks:

Are we really helping minors by keeping them from medical marijuana at all costs? Or are we treating their parents like children?

Do you know what position your presidiential candidates takes on this issue? A press release issued by Reason Foundation points out:

The two major presidential candidates have taken completely opposite positions on medical marijuana and the DEA raids. Last month, Oregon's Willamette Week asked Sen. Barack Obama, "Would you stop the DEA's raids on Oregon medical marijuana growers?" Obama responded, "I would because I think our federal agents have better things to do, like catching criminals and preventing terrorism."

In March, Obama told Oregon's Mail Tribune, "When it comes to medical marijuana, I have more of a practical view than anything else. I mean, my attitude is that if it's an issue of doctors prescribing medical marijuana as a treatment for glaucoma or as a cancer treatment, I think that should be appropriate because there really is no difference between that and a doctor prescribing morphine or anything else."

The Republican National Committee attacked Sen. Obama's response to the Willamette Week's question and Sen. John McCain says he'll continue the Bush administration's aggressive efforts. McCain, who once supported states' rights on the issue, now says, "I don't believe that medical marijuana is necessary for alleving pain, relief of pain. I don't believe it's healthy…I believe it is a national issue and not a statewide issue."

When asked what he'd do to stop federal raids in states where voters have made medical marijuana legal, McCain said, "Nothing."

You can view Drew Carey's other medical marijuana video HERE and additional Drew Carey videos HERE.

The Drug Policy Alliance Network offers lots of additional information including Marijuana: The Facts and Medical Marijuana Fact Sheet.