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news.Osmotica Pharmaceutical has received notice of final approval for its venlafaxine hydrochloride extended-release 37.5mg, 75mg, 150mg and 225mg tablets NDA from FDA for major depressive disorder and social anxiety disorder.
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The Osmotica product provides a controlled release tablet form of venlafaxine hydrochloride including previously unavailable 225mg dosage strength. Equal doses of venlafaxine HCl extended-release tablets are bioequivalent to Effexor XR capsules, a 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, said: “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.”