USFDA approves Sun Pharma's generic Venlafaxine Hydrochloride Extended Release tablets ANDA

Sun Pharma announced that USFDA has granted an approval for an Abbreviated New Drug Application (ANDA) to market a generic version of Venlafaxine Hydrochloride Extended Release tablets.

These generic extended release Venlafaxine tablets are therapeutically equivalent to Osmotica's Venlafaxine Hydrochloride Extended Release tablets and include three strengths: 37.5 mg (base), 75 mg (base), 150 mg (base).

Venlafaxine Hydrochloride extended release tablets are indicated for the management of major depressive disorder.

The product will reach the market shortly.

Source:

 Sun Pharmaceutical Industries Ltd.

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