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Faulding Receives FDA Approval for Generic Version of Ziac(R)

Strategic Insights

— 1 min read

Faulding, an international pharmaceutical and health care company, announced that its US-based Purepac oral generic business has received final approval from the FDA to manufacture and market bisoprolol fumerate and hydrochlorothiazide tablets, a generic version of Lederle's Ziac(R) brand tablets. The product is indicated for the treatment of hypertension and is expected to compete with brand sales valued at over $190 million in 1999. This is Purepac's second FDA approval this financial year, with ten applications currently on file with the FDA.

Key Takeaways:

  • Faulding's Purepac oral generic business has received final approval from the FDA to manufacture and market bisoprolol fumerate and hydrochlorothiazide tablets in 2.5 mg / 6.25 mg, 5 mg / 6.25 mg, and 10 mg / 6.25 mg strengths.
  • The product is the generic version of Lederle's Ziac(R) brand tablets, indicated for the treatment of hypertension.
  • Tentative approval for the product was announced in May 2000, with the product's commercial launch commencing after the expiration of Lederle's pediatric exclusivity on September 24, 2000.
  • Purepac currently has ten applications on file with the FDA.
  • Faulding's products are sold in over 70 countries and the company operates in the generic oral and injectable pharmaceuticals, consumer health products, and distribution and retail management services to pharmacies and logistics management services to hospitals.
  • The brand sales for bisoprolol fumerate and hydrochlorothiazide tablets were estimated to be over $190 million for 1999.

Statistics:

  • $190 million: estimated brand sales for bisoprolol fumerate and hydrochlorothiazide tablets in 1999
  • 2.5 mg / 6.25 mg, 5 mg / 6.25 mg, and 10 mg / 6.25 mg: strengths of bisoprolol fumerate and hydrochlorothiazide tablets
  • 70: number of countries where Faulding's products are sold
  • 10: number of applications on file with the FDA at Purepac

Sources:

  • Faulding Company Announcement, September 26, 2000. Faulding website: www.faulding.com

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