Caplin Steriles gets USFDA nod for generic VAZCULEP injection
Phenylephrine Hydrochloride Injection is indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia;
Chennai: Caplin Steriles Limited, a Subsidiary Company of Caplin Point Laboratories Limited, has been granted final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Phenylephrine Hydrochloride injection USP, 10 mg/mL Single-Dose Vial, 50 mg/5 mL (10mg/mL) Pharmacy Bulk Package, and 100 mg/10 mL (10 mg/mL) Pharmacy Bulk Package, a generic therapeutic equivalent version of (RLD), VAZCULEP Injection, of Avadel Legacy Pharmaceuticals LLC.
According to IQVIATM (IMS Health), Phenylephrine Hydrochloride injection USP had US sales data of approximately $45 million for the 12-month period ending Mar 2020. Caplin Steriles Limited has developed and filed 17 ANDAs on its own and with partners, with 9 approvals so far.
Phenylephrine Hydrochloride Injection is indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia.
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.