Elite Laboratories, Inc. et al.; Withdrawal of Approval of 16 Abbreviated New Drug Applications; Correction
Published . Updated .
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register on June 3, 2026. The document announced the withdrawal of approval of 16 abbreviated new drug applications (ANDAs) from multiple applicants, withdrawn as of July 6, 2026. The document indicated that FDA was withdrawing approval of ANDA 207366 for ribavirin solution, 6 grams/vial, held by Navinta LLC, 1499 Lower Ferry Rd., Ewing, NJ 08618; ANDA 212957 for fosaprepitant dimeglumine powder, Equivalent to (EQ) 150 milligrams (mg) base/vial, held by Navinta LLC; and ANDA 218638 for nicardipine hydrochloride (HCl) capsule, 20 mg and 30 mg, held by Navinta LLC. Before FDA withdrew the approval of these ANDAs, Navinta LLC informed FDA that they did not want the approval of the ANDAs withdrawn. Because Navinta LLC timely requested that approval of the ANDAs not be withdrawn, the approval is still in effect. This notice removes the entries for ANDA 207366, ANDA 212957, and ANDA 218638.
Directly affected
- No company is named in this report.
Indirectly affected
- ACHC ACADIA HEALTHCARE COMPANY INC
GA selected ACHC as a RELATED security because its canonical security name directly matches this event's themes: healthcare. This is an explainable DERIVED market relationship, not a claim that the security was named in the source article.
- ASND ASCENDIS PHARMA A/S
GA selected ASND as a RELATED security because its canonical security name directly matches this event's themes: pharma. This is an explainable DERIVED market relationship, not a claim that the security was named in the source article.
- ATYR ATYR PHARMA INC COM NEW
GA selected ATYR as a RELATED security because its canonical security name directly matches this event's themes: pharma. This is an explainable DERIVED market relationship, not a claim that the security was named in the source article.
- BBIO BRIDGEBIO PHARMA INC
GA selected BBIO as a RELATED security because its canonical security name directly matches this event's themes: pharma. This is an explainable DERIVED market relationship, not a claim that the security was named in the source article.
- DVA DaVita HealthCare Partners, Inc.
GA selected DVA as a RELATED security because its canonical security name directly matches this event's themes: healthcare. This is an explainable DERIVED market relationship, not a claim that the security was named in the source article.
- GEHC GE HEALTHCARE TECHNOLOGIES I
GA selected GEHC as a RELATED security because its canonical security name directly matches this event's themes: healthcare. This is an explainable DERIVED market relationship, not a claim that the security was named in the source article.
Price reaction, T-5 to T+3
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register on June 3, 2026. The document announced the withdrawal of approval of 16 abbreviated new drug applications (ANDAs) from multiple applicants…
Source: Federal Register
The price since 8 Oct 2026: Acadia Healthcare (ACHC) versus the S&P 500
Since the first closing price after “Elite Laboratories, Inc. et al.; Withdrawal of Approval of 16 Abbreviated New Drug Applications; Correction,” Acadia Healthcare (ACHC) is +3.23%. The S&P 500 fund (SPY) is -1.53% over the same days, a +4.76% difference versus the market.
Who reported a Acadia Healthcare (ACHC) trade near this story
- Gilbert Cisneros sell BridgeBio Pharma (BBIO) ($1,001 - $15,000). That is 9 days before publication, inside 30 days. The filing is listed beside the story “Elite Laboratories, Inc. et al.; Withdrawal of Approval of 16 Abbreviated New Drug Applications; Correction.”
- Rohit Khanna buy GE HealthCare Technologies (GEHC) ($1,001 - $15,000). That is 27 days before publication, inside 30 days. The filing is listed beside the story “Elite Laboratories, Inc. et al.; Withdrawal of Approval of 16 Abbreviated New Drug Applications; Correction.”
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).
Who gains and who loses around Acadia Healthcare (ACHC)
Companies tied to this story
- ACHC Acadia Healthcare
In “Elite Laboratories, Inc. et al.; Withdrawal of Approval of 16 Abbreviated New Drug Applications; Correction,” Acadia Healthcare (ACHC) is linked, with no stored direction, medium confidence. Reason on file: GA selected ACHC as a RELATED security because its canonical security name directly matches this event's themes: healthcare. This is an explainable DERIVED market relationship, not a claim that the security was named in the source article
- ASND Ascendis Pharma A/S
For “Elite Laboratories, Inc. et al.; Withdrawal of Approval of 16 Abbreviated New Drug Applications; Correction,” Ascendis Pharma A/S (ASND) is linked, with no stored direction, medium confidence. Reason on file: GA selected ASND as a RELATED security because its canonical security name directly matches this event's themes: pharma. This is an explainable DERIVED market relationship, not a claim that the security was named in the source article
- ATYR aTYR PHARMA
In “Elite Laboratories, Inc. et al.; Withdrawal of Approval of 16 Abbreviated New Drug Applications; Correction,” aTYR PHARMA (ATYR) is linked, with no stored direction, medium confidence. Reason on file: GA selected ATYR as a RELATED security because its canonical security name directly matches this event's themes: pharma. This is an explainable DERIVED market relationship, not a claim that the security was named in the source article
- BBIO BridgeBio Pharma
For “Elite Laboratories, Inc. et al.; Withdrawal of Approval of 16 Abbreviated New Drug Applications; Correction,” BridgeBio Pharma (BBIO) is linked, with no stored direction, medium confidence. Reason on file: GA selected BBIO as a RELATED security because its canonical security name directly matches this event's themes: pharma. This is an explainable DERIVED market relationship, not a claim that the security was named in the source article
- DVA Davita
Davita (DVA) is linked, with no stored direction, medium confidence in the 8 Oct 2026 story “Elite Laboratories, Inc. et al.; Withdrawal of Approval of 16 Abbreviated New Drug Applications; Correction.” Reason on file: GA selected DVA as a RELATED security because its canonical security name directly matches this event's themes: healthcare. This is an explainable DERIVED market relationship, not a claim that the security was named in the source article
- GEHC GE HealthCare Technologies
GE HealthCare Technologies (GEHC) is linked, with no stored direction, medium confidence in the 8 Oct 2026 story “Elite Laboratories, Inc. et al.; Withdrawal of Approval of 16 Abbreviated New Drug Applications; Correction.” Reason on file: GA selected GEHC as a RELATED security because its canonical security name directly matches this event's themes: healthcare. This is an explainable DERIVED market relationship, not a claim that the security was named in the source article
Acadia Healthcare (ACHC)
The 8 Oct 2026 story “Elite Laboratories, Inc. et al.; Withdrawal of Approval of 16 Abbreviated New Drug Applications; Correction” names Acadia Healthcare (ACHC) because of this story.
What ties Acadia Healthcare (ACHC) to the headline is this: GA selected ACHC as a RELATED security because its canonical security name directly matches this event's themes: healthcare. This is an explainable DERIVED market relationship, not a claim that the security was named in the source article
A second company, Ascendis Pharma A/S (ASND), is listed for a different reason: GA selected ASND as a RELATED security because its canonical security name directly matches this event's themes: pharma. This is an explainable DERIVED market relationship, not a claim that the security was named in the source article
Dates and price levels for Acadia Healthcare (ACHC)
ACHC traded between 26.75 and 32.03 across 20 sessions. The latest close on file is 30.20. ASND traded between 219.69 and 240.84 across 20 sessions. The latest close on file is 229.99. ATYR traded between 0.17 and 0.41 across 20 sessions. The latest close on file is 0.17.
What the saved facts support for Acadia Healthcare (ACHC)
54 out of 100
“Elite Laboratories, Inc. et al.; Withdrawal of Approval of 16 Abbreviated New Drug Applications; Correction” scores 54 out of 100. The score uses 2 sources, and 6 linked companies.