Thursday, 26 December 2013

Sun Pharma gets US FDA nod for Sanfoi’s DDAVP Nasal Spray Generic

Sun Pharmaceutical Industries has received US Food and Drug Administration (US FDA) approval for Sanfoi’s DDAVP nasal Spray Generic, which is indicated as antidiuretic replacement therapy in the management of central cranial diabetes insipidus and for management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region.

The use of DDAVP Nasal Spray in patients with an established diagnosis will result in a reduction in urinary output with increase in urine osmolality and a decrease in plasma osmolality.

Recently, the company’s subsidiary granted the USFDA final approval for its Abbreviated New Drug Application (ANDA) to market a generic version of Cymbalta, Duloxetine Delayed-Release Capsules USP, 20 mg, 30 mg and 60 mg. Duloxetine Delayed-Release Capsules USP, 20 mg, 30 mg and 60 mg are therapeutic equivalents of Eli Lilly & Company’s Cymbalta Delayed-Release Capsules.

Sun Pharmaceutical Industries is an international, integrated, specialty pharmaceutical company. It manufactures and markets a large basket of pharmaceutical formulations as branded generics as well as generics in India, US and several other markets across the world.

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