Unichem Laboratories gets USFDA nod to market generic version of tolterodine tartrate tablets

Unichem Laboratories Ltd on Thursday said it has received approval from the US health regulator to market its generic version of tolterodine tartrate tablets used in the treatment of overactive urinary bladder. The tablets are indicated for treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. The product will be commercialised from Unichem's Goa plant, the company said..

Unichem Laboratories Ltd on Thursday said it has received approval from the US health regulator to market its generic version of tolterodine tartrate tablets used in the treatment of overactive urinary bladder. The approval by the US Food and Drug Administration (USFDA) to market tolterodine tartrate tablets is for strengths of 1 mg and 2 mg, Unichem Laboratories said in a regulatory filing.

The tolterodine tartrate tablets are generic versions of Pfizer Inc's DETROL tablets, it added. The tablets are indicated for treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.

The product will be commercialised from Unichem's Goa plant, the company said..

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