Federal Register #251 0096

EPA Superfund Cleanup and FTC Review of Aurobindo-Lannett Pharmaceutical Acquisition

This summary covers two distinct regulatory actions involving federal agencies:

• Environmental Protection Agency (EPA) Region 7:
  • Conducted a time-critical removal action at the Recycletronics-Akron Farm Facility Superfund Site in Iowa
  • Removed approximately 944 tons of lead-containing cathode ray tube glass
  • Negotiated cost recovery settlements with WM Recycle America, L.L.C. and Dynamic Lifecycle Innovations, Inc.
• Federal Trade Commission (FTC):
  • Reviewing Aurobindo Pharma Limited's proposed acquisition of Lannett Company, Inc.
  • Both Aurobindo and Lannett are major OEMs in the generic pharmaceutical market
  • Acquisition impacts four generic drug markets:
  • Mycophenolate mofetil oral suspension (200 mg/mL)
  • Niacin extended release (ER) tablets (500 mg and 1,000 mg)
  • Pilocarpine tablets (5 mg and 7.5 mg)
  • Rabeprazole sodium delayed release (DR) tablets
  • FTC requires divestiture of all rights and assets for these products to Quagen Pharmaceuticals Inc. to preserve competition
• No specific product quantities or part numbers are provided for the pharmaceuticals
• The EPA action is focused on environmental remediation, while the FTC action is focused on maintaining competition in pharmaceutical markets

Description

This notice concerns a proposed consent agreement involving Aurobindo Pharma Limited, Aurobindo Pharma USA, Inc., and Lannett Company, Inc. The agreement addresses alleged violations of federal law prohibiting unfair methods of competition related to Aurobindo's proposed acquisition of Lannett. The acquisition would affect competition in four generic pharmaceutical markets: mycophenolate mofetil oral suspension, niacin extended release tablets, pilocarpine tablets, and rabeprazole sodium delayed release tablets. The consent agreement requires divestiture of rights and assets related to these products to Quagen Pharmaceuticals Inc. to maintain competition. Public comments are invited until July 23, 2026.

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