Osmotica Pharmaceutical Receives FDA Approval To Market Novel Forms Of Extended Release Venlafaxine HCl

Main Category: Depression
Also Included In: Regulatory Affairs / Drug Approvals;  Anxiety / Stress
Article Date: 26 May 2008 - 5:00 PDT

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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