January 22, 2006 - 7:42pm
First-Time Generic Approvals - December 2005
Tablets/Capsules Only
| Generic Drug Name |
Generic Manufacturer |
Referenced Brand Name |
Approval Date |
|---|---|---|---|
| RIBAVIRIN TABLETS, 200 MG, 400 MG, AND 600 MG | THREE RIVERS PHARMACEUTICALS,
LLC |
COPEGUS TABLETS | 12-05-05 |
| RIBAVIRIN TABLETS, 200 MG | ZYDUS PHARMACEUTICALS | COPEGUS TABLETS | 12-05-05 |
| RIBAVIRIN TABLETS, 200 MG | TEVA PHARMACEUTICALS | COPEGUS TABLETS | 12-05-05 |
| ZONISAMIDE CAPSULES, 25 MG, 50 MG, AND 100 MG | ALPHAPHARM | ZONEGRAN CAPSULES | 12-22-05 |
| ZONISAMIDE CAPSULES, 25 MG, 50 MG, AND 100 MG | TEVA PHARMACEUTICALS | ZONEGRAN CAPSULES | 12-22-05 |
| ZONISAMIDE CAPSULES, 25 MG, 50 MG, AND 100 MG | APOTEX | ZONEGRAN CAPSULES | 12-22-05 |
| ZONISAMIDE CAPSULES, 25 MG, 50 MG, AND 100 MG | SANDOZ | ZONEGRAN CAPSULES | 12-22-05 |
| ZONISAMIDE CAPSULES, 25 MG, 50 MG, AND 100 MG | BARR LABORATORIES | ZONEGRAN CAPSULES | 12-22-05 |
| ZONISAMIDE CAPSULES, 25 MG, 50 MG, AND 100 MG | ROXANE LABORATORIES | ZONEGRAN CAPSULES | 12-22-05 |
| ZONISAMIDE CAPSULES, 100 MG | DR. REDDY'S LABORATORIES | ZONEGRAN CAPSULES | 12-22-05 |
| ZONISAMIDE CAPSULES, 100 MG | WOCKHARDT LIMITED | ZONEGRAN CAPSULES | 12-22-05 |
| ZONISAMIDE CAPSULES, 25 MG, 50 MG, AND 100 MG | MYLAN PHARMACEUTICALS | ZONEGRAN CAPSULES | 12-22-05 |
| ZONISAMIDE CAPSULES, 25 MG, 50 MG, AND 100 MG | MUTUAL PHARMACEUTICAL | ZONEGRAN CAPSULES | 12-22-05 |
| OXYCODONE AND ACETAMINOPHEN TABLETS USP, 2.5 MG/300 MG, 5 MG/300
MG, 7.5 MG/300 MG, AND 10 MG/300 MG |
MIKART | NO EQUIVALENTS | 12-22-05 |
| CABERGOLINE TABLETS, 0.5 MG | PAR PHARMACEUTICAL | DOSTINEX TABLETS | 12-29-05 |
Pharmer.org Pill Identifier - Oxycodone/Acetaminophen Imprints
Updated 03-09-06
February 8, 2006 - 9:59pm
#2
Dr. Reddy's Zonisamide
Dear roneyc,
We are very concerned about your son's experience, and we sincerely empathize.
Dr. Reddy's zonisamide 100 mg was approved by the FDA in late December 2005. Only six weeks have elapsed since approval, and we can't find any information - positive or negative.
The 100 mg strength is the only approval for the company, and it is the strongest dosage form. Was your son on 100 mg Zonegran or a lesser dose?
We suggest that you or your son's doctor (preferably both you and the doctor) file a report with MedWatch, the FDA's reporting program for adverse events. The reports alert the US Food and Drug Administration to problems caused by specific drugs.
The internet address is:
http://www.fda.gov/medwatch/report/consumer/consumer.htm
Quote:
MedWatch Reporting by Consumers
MedWatch is the Food and Drug Administration's (FDA) program for reporting serious reactions, product quality problems and product use errors with human medical products, such as drugs and medical devices.
If you think you or someone in your family has experienced a serious reaction to a medical product, you are encouraged to take the reporting form to your doctor. Your health care provider can provide clinical information based on your medical record that can help us evaluate your report.
However, we understand that for a variety of reasons, you may not wish to have the form filled out by your health care provider, or your health care provider may choose not to complete the form. Your health care provider is NOT required to report to the FDA. In these situations, you may complete the Online Reporting Form yourself via the internet.
You will receive an acknowledgement from FDA after we receive your report. You will be personally contacted only if we need additional information.
Please do not delay reporting your son's experience. His health is vital. Besides reporting to the FDA, you or your son's doctor need to advise the insurance company and pharmacy.
Your
son's doctor can also write another prescription dispensed for BRAND
NAME ONLY. You will pay more - a quick search at Walgreen's
states the savings is $123 for 100 capsules generic versus
brand. Other pharmacies might be less expensive so call around
and ask. And ask what generic the pharmacy carries. There
are eight or nine 100 mg generics approved
in December - possibly another generic will be more compatible.
We wish you and your son the best. Please keep us updated.
February 9, 2006 - 7:05am
#3
Thank you for the
Thank you for the information on reporting to MedWatch. I will ask that his doctor begin this process. We have already begun the insurance appeal process and I am preparing to pay the difference in cost between brand and generic pending that appeal. The individual pill strength is maximum 100 mg, but most epilepsy protocols call for 300-500 mg Zonegran on monotherapy. My son is at the 300 mg level and seemed to be doing nicely. So the cost differential is 3x your estimate.
I wish to emphasize that this is not an indictment of Dr. Reddy's lab. My request was sincerely for information and due to the newness of the approval, I didn't really think there would be much evidence in the record yet. But I had to start somewhere. Control of epileptic seizure is an art form, as my sons physicians continually remind me. There are too many variables to insist that the change to a generic medication is the proximate cause of his seizure. I believe that removing this variable by returning to the brand name is a reasonable decision as we attempt to control his condition.
Thank you again for your response.
February 22, 2006 - 9:24am
#4
Zonisamide Generic (Mylan)
If this comes out wrong, it's because I've been taking this
generic for 4 days now and I can't think straight anymore. I
think I hit the wrong button earlier and sent a blank message.
This one is taking quite a while to type. I've been seizure free
for the past 5 years (grand mal), but with this generic I can't think,
my nerves are jumpy, my muscles twitch, my brain feels hollow, (no
comments necessary) and I feel like c**p. I'm going to the Dr.
today to get this straighted yout. I'll pay the difference if
necessary, if I can come up with the money. I'm 47 years old, and
I guess health comes with a price tag. Generic is trash when it
comes to epilepsy- Mark
Does anyone have information regarding effectiveness of this recently approved generic? My insurance insisted we use generic or pay the differential with Zonegran. Four days after switching, my son suffered a breakthrough seizure. We're appealing the coverage and could use any info on other failures with this or similar products manufactured by Dr. Reddy's labs.