FDA nod for Cipla's Generic Vazculep ® and Phenylephrine Hydrochloride

  • Posted on: 2 May 2018
  • By: admin

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Cipla Limited, a global pharmaceutical company, 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).

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

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