Zydus has received final approval from the US FDA to market four of its new drugs – Amitriptyline Hydrochloride tablets, Fesoterodine Fumarate extended-release tablets, Desmopressin nasal spray solution, and Dutasteride capsules.
Amitriptyline Hydrochloride tablets USP in strengths of 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, and 150 mg is used to treat depression. Fesoterodine Fumarate extended-release tablets, 4 mg and 8 mg are used to treat an overactive bladder with symptoms of urinary frequency, urgency, and incontinence. The sales of Fesoterodine Fumarate extended-release tablets are estimated at USD 195.5 million.
Desmopressin nasal spray solution USP, 10 mcg/0.1 mL per spray, 5 mL bottle. Desmopressin nasal spray is indicated as an antidiuretic replacement therapy in the management of central diabetes insipidus, polyuria (excessive urination), and polydipsia (drinking excessive amounts of fluids) following head trauma or surgery in the pituitary region and nocturia (excessive urination at night). Dutasteride capsules, 0.5 mg are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to improve symptoms, reduce the risk of acute urinary retention (AUR), and reduce the risk of the need for BPH-related surgery.
The drugs will be manufactured at the group's formulations manufacturing facility in Ahmedabad. The group now has more than 160 approvals and has so far filed over 300 ANDAs since the commencement of the filing process in FY 2003-04.