Merck Receives FDA Approval for Extended Marketing Exclusivity of Pepcid

Strategic Insights -

Merck & Co., Inc., a leading research-driven pharmaceutical company, has announced that the Food and Drug Administration (FDA) has granted six additional months of marketing exclusivity to Pepcid (famotidine) in response to a supplemental new drug application (sNDA) submitted by the company. This decision delays FDA approval of generic famotidine until April 15, 2001, thereby preserving Merck's market share and revenue from the blockbuster medication. The FDA's decision was made under the provisions of the FDA Modernization Act of 1997 (FDAMA), which incentivizes pharmaceutical companies to conduct pediatric studies for certain medications that may benefit children.

Key Takeaways:

  • The FDA granted six additional months of marketing exclusivity to Pepcid (famotidine) in response to Merck's supplemental new drug application (sNDA).
  • This decision will delay FDA approval of generic famotidine until April 15, 2001, thereby preserving Merck's market share and revenue.
  • Merck submitted the sNDA on August 28, 2000, in response to a Written Request from the FDA seeking pediatric studies.
  • The study data submitted by Merck is still under review by the FDA, with no change to the prescribing information for Pepcid.
  • Pepcid is a prescription medication used to treat acid reflux, stomach ulcers, and abnormally high levels of stomach acid.
  • The most common side effects of Pepcid are headache, dizziness, constipation, and diarrhea.
  • Merck & Co., Inc. is a leading research-driven pharmaceutical company with a broad range of innovative products to improve human and animal health.

Statistics:

  • The FDA granted six additional months of marketing exclusivity to Pepcid (famotidine).
  • The extended marketing exclusivity will delay FDA approval of generic famotidine until April 15, 2001.
  • Merck submitted the sNDA on August 28, 2000.
  • The study data submitted by Merck is still under review by the FDA.
  • Pepcid is indicated for the short-term treatment of acid reflux and stomach ulcers (75% of patients) and the treatment of abnormally high levels of stomach acid (20% of patients).

Sources:

  • Merck & Co., Inc.
  • Food and Drug Administration (FDA)
  • FDA Modernization Act of 1997 (FDAMA)
  • PrNewswire
  • Merck & Co., Inc. Press Release (dated November 21, 2000)