Cipla, a global pharmaceutical company, has received US FDA final approval for its 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.

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 anaesthesia. 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 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. The product will be available for shipping in the near future.
 
Cipla’s exemestane tablets, 25mg, is an AB-rated generic equivalent of Pfizer’s Aromasin, and is indicated for treatment of certain types of breast cancer in postmenopausal women. The product will be available for shipping in the near future.

According to IQVIA (IMS) Health, Vazculep and generic equivalents had US sales of approximately $56 million and Aromasin and generic equivalents had US sales of approximately $77 million for the 12-month period ending February 2018.

The products are manufactured at the Cipla’s Goa plant.