Biopharmaceuticals Generics FDA

 News Release - December 22, 2020

Nephron Announces FDA Approval of Ketorolac, Signaling New Phase of Growth

Kennedy: Company Excited to Expand Generic Portfolio to Include Non-Respiratory Products

WEST COLUMBIA, S.C., Dec. 22, 2020 -- (Healthcare Sales & Marketing Network) -- Nephron Pharmaceuticals Corporation is celebrating another milestone.

The company today announced Food and Drug Administration (FDA) approval of the Nephron Abbreviated New Drug Application (ANDA) for ketorolac tromethamine Injection USP, 60 mg/2 mL (30 mg/mL) in Single-Dose Vials. The vials are made of polypropylene plastic with a "luer lock" interface for needle-free dosing and are manufactured using Blow-Fill-Seal (BFS) technology.

ketorolac tromethamine becomes one of the first ANDA-approved non-respiratory generic medications produced by Nephron, signaling a new phase of company growth. Nephron secured FDA approval for Sodium Chloride IV Bags earlier this year.

"We are extraordinarily excited to expand our generic medication portfolio to include non-respiratory products," said Nephron CEO Lou Kennedy. "This is the latest sign that Nephron is growing, and it represents a real reason for our entire team to celebrate."

Nephron-manufactured ketorolac tromethamine is an injectable medication for the short-term treatment (up to 5 days) of moderately severe acute pain. Commonly used after surgeries and other medical procedures, ketorolac tromethamine is a nonsteroidal anti-inflammatory drug (NSAID).

A West Columbia, S.C.-based company, Nephron develops and produces safe, affordable generic inhalation solutions and suspension products.

The company also operates an industry-leading 503B Outsourcing Facility division which produces pre-filled sterile syringes and IV bags for hospitals across America, in an effort to alleviate their drug shortage needs. The company recently opened a CLIA-certified diagnostics lab and conducts COVID-19 tests for people across South Carolina.

Prescribing Information for ketorolac tromethamine Injection Vial UPS, 60 mg/2 mL (30 mg/mL) is Available on the product package insert. More product information regarding ketorolac tromethamine Injection USP, 60 mg/2 mL (30 mg/mL) in Single-Dose Vials is available here.

Source: Nephron Pharmaceuticals

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