Osmotica Pharmaceutical Corp. has 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.
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