Cipla receives final approval for Phenylephrine Hydrochloride Injection, Exemestane Tablets

Cipla Ltd. | Pharmaceuticals & Drugs | Healthcare | BSE: 500087 | NSE: CIPLA

02 May 2018 Evaluate

Cipla 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 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. 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.

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

Cipla is a global pharmaceutical company which uses cutting edge technology and innovation to meet the everyday needs of all patients. The company’s portfolio includes over 1500 products across wide range of therapeutic categories with one quality standard globally.

Cipla Share Price

1438.75 -2.95 (-0.20%)

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