Osmotica Pharmaceutical Corp and Upstate Pharma, LLC, a subsidiary of UCB, Inc., Announce the Availability of Venlafaxine Extended-Release Tablets
WILMINGTON, N.C., Thursday October 9, 10:41 am ET --(BUSINESS WIRE)-- Osmotica Pharmaceutical Corp. is announcing that Venlafaxine Extended-Release Tablets, 37.5 mg, 75 mg, 150 mg, and 225 mg, which was approved by the U.S. Food and Drug Administration in May, is now commercially available through its marketing partner, Upstate Pharma, LLC, a subsidiary of UCB, Inc. Shipments of the product to wholesalers and other commercial outlets began September 30, 2008 and promotion of the product will commence later in the month. Forrest Waldon, CEO of Osmotica Pharmaceutical stated, “We are excited about the launch of this innovative product and look forward to a successful commercial relationship.”
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 Monoamine oxidase inhibitors (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 its products are manufactured in the U.S., Argentina and Spain.
For more information on the Company, please visit Osmotica’s website at www.osmotica.com. This press release is directed to residents of the United States.
Contact:
Osmotica Pharmaceutical Corp.
William H. Underwood
Sr. Vice President, Business Development
910-509-0114
Contact Osmotica
Osmotica Pharmaceutical Receives FDA Approval to Market Novel Forms of Extended Release Venlafaxine HCl.
Wilmington, N.C., May 23, 2008 – 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.
For more information on the Company, please visit Osmotica’s website at www.osmotica.com. This press release is directed to residents of the United States.
Contact:
William H. Underwood
Sr. Vice President, Business Development
910 509 0114
Contact Osmotica