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Paddock Laboratories LLC

Division of Perrigo Co. PLC
www.paddocklabs.com

Latest From Paddock Laboratories LLC

OTC-Only PEG Market Nears After Court Passes On Stopping Rx ANDA Withdrawals

US circuit court rejects petitions from Breckenridge Pharmaceutical, Lannett Co., Nexgen Pharma and Paddock Labs to order FDA to conduct a hearing on their requests to sustain approvals for Rx PEG 3350 generics. FDA's approvals of the Rx ANDAs are set to expire Nov. 2; the agency said the Rx products were rendered unapproved in 2006 when the same formulation became available OTC.

Gastrointestinal Health

OTC-Only PEG Market Nears After Court Passes On Stopping Rx ANDA Withdrawals

US circuit court rejects petitions from Breckenridge Pharmaceutical, Lannett Co., Nexgen Pharma and Paddock Labs to order FDA to conduct a hearing on their requests to sustain approvals for Rx PEG 3350 generics. FDA's approvals of the Rx ANDAs are set to expire Nov. 2; the agency said the Rx products were rendered unapproved in 2006 when the same formulation became available OTC.

Gastrointestinal Legal Issues

PEG 3350 Laxatives: FDA Allows Firms 6 Months To Make Their Case For Rx Products

FDA agrees with Breckenridge Pharmaceutical, Nexgen Pharma, Lannett Co. and Paddock Labs that ending availability of their Rx PEG 3350 products on May 2 would cause a shortage of the drug available to consumers. Saying "it likely would be difficult for manufacturers of OTC PEG 3350 products to compensate for the removal" of the Rx drugs by that date, FDA extends the deadline to Nov. 2.

Prescription To Otc Switch Gastrointestinal

PEG 3350 Laxatives: FDA Allows Firms 6 Months To Make Their Case For Rx Products

FDA agrees with Breckenridge Pharmaceutical, Nexgen Pharma, Lannett Co. and Paddock Labs that ending availability of their Rx PEG 3350 products on May 2 would cause a shortage of the drug available to consumers. Saying "it likely would be difficult for manufacturers of OTC PEG 3350 products to compensate for the removal" of the Rx drugs by that date, FDA extends the deadline to Nov. 2.

Prescription To Otc Switch Gastrointestinal
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Company Information

  • Industry
  • Pharmaceuticals
    • Generic Drugs
    • OTC, Consumer
  • Therapeutic Areas
  • Non-Specific
  • Alias(es)
  • Paddock Laboratories Inc.
  • Ownership
  • Private
  • Headquarters
  • Worldwide
    • North America
      • USA
  • Parent & Subsidiaries
  • Perrigo Co. PLC
  • Senior Management
  • Contact Info
  • Paddock Laboratories LLC
    Phone: (763) 546-4676
    3940 Quebec Ave N.
    Minneapolis, MN 55427
    USA
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