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Caplin Steriles has been granted final approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) neostigmine methylsulfate injection USP, 5 mg/10 mL (0.5 mg/mL) and 10 mg/10 mL (1 mg/mL).
Lead Product(s): Milrinone Lactate
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Undisclosed
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 22, 2021
Details:
Caplin Steriles has been granted final approval from the USFDA for its ANDA Milrinone Lactate Injection USP, 10 mg/10 mL, 20 mg/20 mL, 50 mg/50 mL, Single-dose vial presentation, a generic therapeutic equivalent version of, PRIMACOR Injection, 1 mg/mL, of Sanofi-Aventis.
Lead Product(s): Milrinone Lactate
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Undisclosed
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 19, 2021
