Cipla gets USFDA approval for generic equivalents of Vazculep, Aromasin

New Delhi: Drug major Cipla has received final approval from the US health regulator for the generic equivalent of Avadel's Vazculep, West Ward Pharm Corp's Phenylephrine Hydrochloride injection and Pfizer's Aromasin.

In a regulatory filing, Cipla said "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, 25 mg from the United States Food and Drug Administration (USFDA)".

Cipla said Phenylephrine Hydrochloride Injection USP, 50 mg/5 mL (10 mg/mL) and 100 mg/10 mL (10 mg/mL) pharmacy bulk package, is an AP-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.

Cipla's Phenylephrine Hydrochloride Injection USP, 10 mg/mL Single-Dose Vial, is an AP-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.

Cipla's exemestane tablets, 25mg, is an AB-rated generic equivalent of Pfizer's Aromasin and is indicated for the treatment of certain types of breast cancer in postmenopausal women.

All these products will be available for shipping in the near future.

Citing IQVIA (IMS) Health data, Cipla said Vazculep and generic equivalents had US sales of approximately USD 56 million for the 12-month period ending February.

Aromasin and generic equivalents had US sales of approximately USD 77 million for the 12-month period ending February 2018, according to IMS Health, it added.

Cipla said the products are manufactured at the company's Goa plant.