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Breckenridge Pharmaceutical Inc.

Division of Esteve Group
bpirx.com

Latest From Breckenridge Pharmaceutical Inc.

Older Patents Get Help As Federal Circuit Sides With Novartis In Gilenya, Everolimus Disputes

US court finds no obviousness-type double patenting under statute that changed patent term from 17 years from issuance to 20 years from filing; decisions will impact other cases involving patents issued prior to statute.
Generic Drugs Legal Issues

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
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Company Information

  • Industry
  • Pharmaceuticals
    • Generic Drugs
    • Nutraceuticals
    • OTC, Consumer
  • Therapeutic Areas
  • Blood & Coagulation Disorders & Products
  • Cancer
  • Cardiovascular
  • Dermatology
  • Gastrointestinal
  • Gynecological, Urological
  • Immune Disorders
  • Infectious & Viral Diseases
  • Metabolic Disorders
  • Neurology, Nervous System
  • Renal System
  • Respiratory, Pulmonary
  • Alias(es)
  • Ownership
  • Private
  • Headquarters
  • Worldwide
    • North America
      • USA
  • Parent & Subsidiaries
  • Esteve Group
  • Senior Management
  • Larry Runsdorf, Pres.
    Marty Schatz , VP, Sales
    Larry J Lapila, EVP, Bus. Dev.
    Todd Ruonavaara, VP, Fin.
  • Contact Info
  • Breckenridge Pharmaceutical Inc.
    Phone: (561) 443-3314
    6111 Broken Sound Pkwy. NW,
    Ste. 170
    Boca Raton, FL 33487
    USA
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