Zydus Cadila has received the final approval from the USFDA to market Dutasteride Capsules, 0.5 mg. It will be manufactured at the group’s formulations manufacturing facility at Moraiya, Ahmedabad. Dutasteride Capsules 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 BPHrelated surgery.
Zydus Cadila also received the final approval from the USFDA to market Fesoterodine Fumarate Extended-Release Tablets, 4 mg and 8 mg. It will be manufactured at the group’s formulations manufacturing facility at Moraiya, Ahmedabad. Fesoterodine is 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 $195.5 million. 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.
Earlier, Zydus Cadila has received the final approval from the USFDA to market Doxycycline for Injection USP , 100 mg per vial and 200 mg per vial (Single-Dose Vial) and tablet. The drug is a broad spectrum antibiotic and is indicated to treat or prevent a variety of infectious disorders that are proven or strongly suspected to be caused by susceptible bacteria. It will be manufactured at group’s formulations manufacturing facility at Moraiya, Ahmedabad.
Zydus Cadila has received final approval from the US health regulator to market anti-diuretic Desmopressin nasal spray solution in the American market. The drug firm has received final approval from the United States Food and Drug Administration (USFDA) to market Desmopressin nasal spray solution USP, 10 mcg/0.1 mL per spray, 5 ml bottle, Zydus Cadila said in a statement today.
The product will be manufactured at the group’s formulations manufacturing facility at Moraiya in Ahmedabad, it added.
The nasal spray is indicated as an anti-diuretic replacement therapy in the management of central diabetes insipidus, excessive urination and drinking excessive amount of fluids following head trauma or surgery in the pituitary region and nocturia, Zydus Cadila said.