Osmotica Pharmaceutical Receives FDA Approval To Market Novel Forms Of Extended Release Venlafaxine HCl
Main Category: DepressionAlso Included In: Regulatory Affairs / Drug Approvals; Anxiety / Stress
Article Date: 26 May 2008 - 5:00 PST
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Osmotica Pharmaceutical Corp. received notice of final approval for its Venlafaxine Hydrochloride Extended-release 37.5 mg, 75 mg, 150 mg and 225 mg tablets NDA from FDA for major depressive disorder and social anxiety disorder. The Osmotica product provides a controlled release tablet form of venlafaxine HCl including a previously unavailable 225 mg dosage strength. Equal doses of venlafaxine HCl Extended-release Tablets are bioequivalent to Effexor XR® capsules, a leading product marketed by Wyeth, when administered under fed conditions. Osmotica expects to launch the new product line for the two FDA-approved indications in the near future.
Forrest Waldon, CEO of Osmotica Pharmaceutical stated, "We are excited about the approval and pending launch of this innovative product. The combination of our Osmodex® controlled release technology with the venlafaxine molecule has allowed us to bring a dosage strength not currently available to the marketplace. We are evaluating proposals from potential marketing partners and expect to make the final marketing decisions in the near future."
Important Safety Information
There is an increased risk of suicidal thinking and behavior in children, adolescents and young adults taking antidepressants for major depressive disorder (MDD) and other psychiatric disorders. Venlafaxine HCl Extended Release Tablets are not approved for use in pediatric patients.
People taking MAOIs should not take Venlafaxine HCl Extended-release Tablets. Venlafaxine HCl Extended-release Tablets may raise blood pressure in some patients. Your blood pressure should be controlled before starting treatment and should be monitored regularly. Other side effects reported in at least 10% of patients in clinical studies and at a rate at least twice that of the placebo group include: abnormal ejaculation (men), anorexia, dizziness, dry mouth, impotence, insomnia, nausea, nervousness, somnolence, sweating, and weakness. Ask your doctor if Venlafaxine HCl Extended-release Tablets are right for you.
About Osmotica Pharmaceutical
Osmotica Pharmaceutical is part of a multi-national group of pharmaceutical companies (the "Osmotica Group") specializing in neurology based drug therapies and delivery technologies. The Osmotica Group has a portfolio of products in various stages of development focused in the treatment of Parkinson's disease. In addition, the Osmotica Group utilizes its well established drug delivery technologies (including its Osmodex® technologies) and its expertise to develop drug candidates for partner companies. The Osmotica Group has a track record of successfully developing and commercializing products in the US, Europe and other countries around the world.
The Osmotica Group's principal operations are located in the United States and Argentina and manufacture its products in the U.S., Argentina and Spain.
http://www.osmotica.com
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MLA
13 Feb. 2012. <http://www.medicalnewstoday.com/releases/108758.php>
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http://www.medicalnewstoday.com/releases/108758.php.
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Visitor Opinions In Chronological Order (3)
Senior Shock!
posted by gail charcholla on 26 Jul 2010 at 10:29 amSeniors on Medicare have been drilled about the importance of using generic drugs instead of brand name, to cut the costs with their Medicare drug programs.
When prescribed Effexor, I insisted on a generic because like many other senior citizens, it sometimes come to choosing between do I buy groceries or medicines. I was prescribed your Venlafaxine which was a tier I drug in my Unicare program and was able to afford my monthly copay. The plan would then pay somewhere in the range of $62.00. This by the way was for a 90 day supply from their mail order plan. All of a sudden their price has jumped to $286.10! This took place between my order of March 2010 and May 2010.
It is true that my copay stays at 10.50, however, both figures, my payment and the plans payment are added together to get to the coverage gap figure, where we seniors go into the so called "donut hole" and have to pay the full price of our drugs for the next 1700+ dollars. True the government is sending out checks for $250 sometime, to help, but that still leaves $1450.00 it will cost us until we reach the catastrophic coverage level. How ridiculous is this?
Whoever heard of quadrupling a price of something so quickly? Is it greed or what? I have called the government offices, medicare, RX plan office etc, and now I am writing to the source. I would like an answer, and I am told some pharmaceutical companies assist seniors with their drug costs, only if they are already in poverty. Having any money more than enough to bury one's self, seems to be considered too well off. I hope I receive some sort of explanation, and I will be able to share it not only with many of my friends who are also buying your products, but with the plan office to assist many others. Please realize the stress and anxiety you are causing the same people who are in need of your medications already!! Thank you for reading my opinion, and I will be waiting to hear from you, and thank you in advance for any assistance you might be able to afford me.
coupons for venlafaxine hcl er
posted by penny on 26 Jul 2010 at 1:57 pmLooking to receive coupons I switch because it was cheaper I did realize the pharmacy gave me a coupon now I dont feel it is that much cheaper than effexor
Penny
undisolved
posted by jennifer on 21 Jul 2011 at 4:46 amI started the generic form of the effexor market by Osmotica Pharmaceutical about one yesr now.
Other than the comon conticipation, my depression is the same-up & down. I take my pills in the morning and # of times I noticed/found the undisolved whole pill in my bowl movement; the coating was so thick like rubber.
I wonder if any other user brought this issue up?
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