Cipla Gets Final ANDA Nod for Phenylephrine Inj, Exemestane Tab | CORPORATE ETHOS

Cipla Gets Final ANDA Nod for Phenylephrine Inj, Exemestane Tab

By: | May 2, 2018
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May 2: Drug maker Cipla Ltd on Wednesday announced 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).

According to a company statement, 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.

The Exemestane Tablets, 25mg, of the company 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 products, which are manufactured at the company’s Goa plant, will be available for shipping in the near future, according to the company.

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