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Novel Laboratories Inc.

Division of Lupin Ltd.
www.novellabs.net

Latest From Novel Laboratories Inc.

ANDA Sponsors In Drivers Seat For Competitive Generic Therapy Exclusivity

Draft guidance says US FDA will not assume a product has launched, the final requirement to receive the promised 180-day exclusivity, unless notified by the sponsor.
Generic Drugs Review Pathway

Lupin Slumps To Q4 Loss Amid US Opioid Action But Build Up In Inhalation, Biosimilars

Lupin ended the fourth quarter in the red hit by an impairment provision related to the "underperforming" assets of its Gavis acquisition but the firm's US inhalation pipeline appears to have made some progress, including a filing for tiotropium dry powder inhaler (DPI). Early stage biosimilars under development include, among others, versions of Neulasta and Xgeva/Prolia.

Commercial Strategy

Weight Of Emergency Contraceptive Data Does Not Support Label Change

Data are "conflicting and too limited to make a definitive conclusion," FDA says after reviewing scientific data concerning effectiveness of Plan B One Step and other 1.5mg levonorgestrel emergency contraceptives in women weighing more than 165 pounds.

BioPharmaceutical Risk Management

Weight Of Emergency Contraceptive Data Does Not Support Label Change

Data are "conflicting and too limited to make a definitive conclusion" FDA says after reviewing scientific data concerning effectiveness of Plan B One Step and other 1.5mg levonorgestrel emergency contraceptives in women weighing more than 165 pounds.

Consumer BioPharmaceutical
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Company Information

  • Industry
  • Pharmaceuticals
    • Drug Delivery
      • Controlled Release
      • Pulmonary
      • Topical Delivery
    • Generic Drugs
  • Services
  • Therapeutic Areas
  • Non-Specific
  • Alias(es)
  • Ownership
  • Private
  • Headquarters
  • Worldwide
    • North America
      • USA
  • Parent & Subsidiaries
  • Lupin Ltd.
  • Senior Management
  • Veerappan Subramanian, PhD, Pres. & CEO
    Arshad Kagalwalla, Dir., Fin. & Accounting
    Bala Nayar, PhD, VP, Special Prod. Dev.
  • Contact Info
  • Novel Laboratories Inc.
    Phone: (908) 603-6000
    400 Campus Dr.
    Somerset, NJ 08873
    USA
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