CHESTERFIELD, Mo., April 16, 2014 /PRNewswire/ -- Amid the FDA and ASHP announced shortages of unapproved Neostigmine Methylsulfate Injection; Eclat Pharmaceuticals is effectively ending the shortages with BLOXIVERZ®, the only FDA-approved Neostigmine Methylsulfate Injection.
BLOXIVERZ is available in two dosage strengths, 0.5 mg/mL and 1 mg/mL, in 10 mL multiple dose vials. All other Neostigmine Methylsulfate Injections are not FDA-approved and are subject to removal by the FDA.
Eclat is also pleased to highlight the Drug Safety White Paper recently published by leading key opinion leaders Cindy Ippoliti, Pharm.D., Christan Thomas, Pharm.D. and Frank Cirrone, Pharm.D., from NYP/Weill Cornell. The White Paper, "The Hazards of Unapproved Drugs and Importance of Utilizing Approved Drugs," emphasizes the need to use FDA-approved drugs.
Each year dozens of drugs that are proven to be safe and effective are approved by the US Food and Drug Administration (FDA). However, many unapproved products remain on the market, "grandfathered" by older regulations. The FDA has expressed serious concerns about the safety and effectiveness of unapproved drugs and launched a safety initiative in 2006 with the goal of removing unapproved drugs from the market.
"The use of unapproved drugs can not only lead to legal action, but also poses a significant public health concern — particularly for those agents that have been previously "grandfathered" into the system. Once an FDA-approved formulation becomes available, early adoption is key for financial peace of mind, patient safety, and quality healthcare delivery. Continued use of non-approved drugs when a safe, FDA-approved product is available is not in the public interest and can lead to legal lawsuits." — Cindy Ippoliti, Pharm.D., NYP/Weill Cornell
Eclat Pharmaceuticals is a multinational pharmaceutical company committed to bringing safe and effective, FDA-approved products to replace older and unapproved drugs. BLOXIVERZ is the only FDA-approved alternative that effectively ends the ongoing shortages of unapproved Neostigmine Methylsulfate Injection. BLOXIVERZ is available with all leading wholesalers. For further information, please visit www.bloxiverz.com and for any questions, please call (636) 449-1830 or email [email protected]
The White paper is available at the ASHP website:
Eclat Pharmaceuticals Contact:
Chris Keith, EVP, Sales & Marketing, Eclat Pharmaceuticals, 702 Spirit 40 Park Drive, Chesterfield, MO 63005, (636) 449-1832
Ravi Sachdev, Expect Advertising, Inc., 1033 Route 46, Clifton, NJ 07013, (973) 777-8886 Ext. 101, [email protected]
SOURCE Eclat Pharmaceuticals