Wednesday 28 May, 2008

Osmotica Pharma got final approval for venlafaxine XR

Osmotica Pharma has got notice of final approval for its venlafaxine hydrochloride extended-release 37.5 mg, 75 mg, 150 mg and 225 mg tablets NDA from USFDA for major depressive disorder. The Osmotica formulation 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.
Osmotica Pharmaceutical is 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.

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