Determination That PEPCID RPD (Famotidine) Orally Disintegrating Tablets, 20 Milligrams and 40 Milligrams Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Published . Updated .
The Food and Drug Administration (FDA, Agency, or we) has determined that PEPCID RPD (famotidine) orally disintegrating tablets, 20 milligrams (mg) and 40 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for famotidine) orally disintegrating tablets, 20 mg and 40 mg, if all other legal and regulatory requirements are met.
Directly affected
- No company is named in this report.
Indirectly affected
- XLV Health Care Select Sector SPDR
Health Care Select Sector SPDR: it holds drugmakers and health companies. Linked by “drug” (pharma and health) in this story.
- XBI SPDR S&P Biotech ETF
SPDR S&P Biotech ETF: it holds drugmakers and health companies. Linked by “drug” (pharma and health) in this story.
- LLY Eli Lilly and+12.6% 30d
Eli Lilly and (pharmaceutical preparations): drugmakers move with drug pricing, approvals and health policy. Linked by “drug” (pharma and health) in this story.
- JNJ Johnson & Johnson+0.5% 30d
Johnson & Johnson (pharmaceutical preparations): drugmakers move with drug pricing, approvals and health policy. Linked by “drug” (pharma and health) in this story.
- PFE Pfizer+8.4% 30d
Pfizer (pharmaceutical preparations): drugmakers move with drug pricing, approvals and health policy. Linked by “drug” (pharma and health) in this story.
- MRK Merck-2.1% 15d
Merck (pharmaceutical preparations): drugmakers move with drug pricing, approvals and health policy. Linked by “drug” (pharma and health) in this story.
Price reaction, T-5 to T+3
| Ticker | T-5 | T-3 | T-1 | T0 | T+1 | T+2 | T+3 |
|---|---|---|---|---|---|---|---|
| XLVNo price data for this ticker | — | — | — | — | — | — | — |
| XBINo price data for this ticker | — | — | — | — | — | — | — |
| LLYNo price data for this ticker | — | — | — | — | — | — | — |
| JNJNo price data for this ticker | — | — | — | — | — | — | — |
| PFENo price data for this ticker | — | — | — | — | — | — | — |
| MRKNo price data for this ticker | — | — | — | — | — | — | — |
Closing-price change versus T-1, the last close before the story. T0 to T+3 fill in after each market close. Prices: Alpaca IEX.
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The Food and Drug Administration (FDA, Agency, or we) has determined that PEPCID RPD (famotidine) orally disintegrating tablets, 20 milligrams (mg) and 40 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determ…
Source: Federal Register
Trades by members of Congress and officials in the stocks in this story
- Rep. Rohit Khanna bought Eli Lilly (LLY) (held by a spouse), worth $1,001 - $15,000 on 4 Sep 2026. That is 52 days before publication. Filed 7 Oct 2026. View the filing.
- Rep. Rohit Khanna bought Johnson & Johnson (JNJ) (held by a spouse), worth $1,001 - $15,000 on 25 Sep 2026. That is 31 days before publication. Filed 7 Oct 2026. View the filing.
- Rep. Lloyd Doggett bought Johnson & Johnson (JNJ), worth $1,001 - $15,000 on 8 Sep 2026. That is 48 days before publication. Filed 5 Oct 2026. View the filing.
- Rep. Rohit Khanna bought Johnson & Johnson (JNJ) (held by a spouse), worth $1,001 - $15,000 on 4 Sep 2026. That is 52 days before publication. Filed 7 Oct 2026. View the filing.
- Rep. Rohit Khanna sold Pfizer (PFE) (held by a spouse), worth $1,001 - $15,000 on 4 Sep 2026. That is 52 days before publication. Filed 7 Oct 2026. View the filing.
- Donald J Trump, an executive branch official, bought Pfizer (PFE), worth $100,001 - $250,000 on 21 Aug 2026. That is 66 days before publication. Filed 8 Oct 2026. View the filing.
- Donald J Trump, an executive branch official, bought Pfizer (PFE), worth $100,001 - $250,000 on 31 Jul 2026. That is 87 days before publication. Filed 22 Sep 2026. View the filing.
- Rep. Maria Elvira Salazar sold Merck (MRK), worth $1,001 - $15,000 on 24 Sep 2026. That is 32 days before publication. Filed 7 Oct 2026. View the filing.
- Rep. Maria Elvira Salazar bought Merck (MRK), worth $15,001 - $50,000 on 19 Aug 2026. That is 68 days before publication. Filed 9 Sep 2026. View the filing.
- Donald J Trump, an executive branch official, sold Merck (MRK), worth $250,001 - $500,000 on 31 Jul 2026. That is 87 days before publication. Filed 22 Sep 2026. View the filing.
Public disclosure filings, not a recommendation. The filing link is the source document. News use of these reports still sits under 5 U.S.C. § 13107(c).
This story
25 out of 100
“Determination That PEPCID RPD (Famotidine) Orally Disintegrating Tablets, 20 Milligrams and 40 Milligrams Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness” scores 25 out of 100. The score uses 2 sources.