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( 02 May 2018)
Cipla bags approval for Generic Vazculep from USFDA

Cipla Limited , a global pharmaceutical company has said that it has received final approval for its Abbreviated New Drug Application (ANDA) for Phenylephrine Hydrochloride Injection USP, 50 mg/5 mL (10 mg/mL) and 100 mg/10 mL (10 mg/mL) Pharmacy Bulk Package, Phenylephrine Hydrochloride Injection USP, 10 mg/mL Single - Dose Vial and Exemestane Tablets, 25mg from the United States Food and Drug Administration (USFDA).

Phenylephrine Hydrochloride Injection USP, 50 mg/5 mL (10 mg/mL) and 100 mg/10 mL (10 mg/mL) Pharmacy Bulk Package , is an A P - rated generic equivalent of Avadel ’s Vazculep® , and is indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia.

The product will be available for shipping in the near future. Cipla’s Phenylephrine Hydrochloride Injection USP, 10 mg/mL Single - Dose Vial , is an A P - rated generic equivalent of West Ward Pharm Corp’s Phenylephrine Hydrochloride Injection, 10 mg/mL and is indicated for increasing blood pressure in adults with clinically important hypotension resulting primarily from vasodilation, in such settings as septic shock or anesthesia.

Meanwhile, shares of the company were trading at Rs 617.40 apiece up 1.77 per cent from the previous close at 09:40 hrs on BSE.