Teva Pharmaceuticals USA, Inc., et al.; Withdrawal of Approval of 15 Abbreviated New Drug Applications; Correction
Published . Updated .
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register on May 7, 2026. The document announced the withdrawal of approval of 15 abbreviated new drug applications (ANDAs) from multiple applicants, withdrawn as of June 8, 2026. The document indicated that FDA was withdrawing approval of ANDA 210285 for dimethyl fumarate delayed-release capsule, 120 milligrams (mg) and 240 mg, held by Upsher-Smith Laboratories, LLC., U.S. Agent for Sawai USA, Inc., 6701 Evenstad Dr. N, Suite 300, Maple Grove, MN 55369. Before FDA withdrew the approval of this ANDA, Upsher-Smith Laboratories, LLC., U.S. Agent for Sawai USA, Inc., informed FDA that they did not want the approval of the ANDA withdrawn. Because Upsher- Smith Laboratories, LLC., U.S. Agent for Sawai USA, Inc., timely requested that approval of the ANDA not be withdrawn, the approval is still in effect. This notice removes the entry for ANDA 210285.
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 May 7, 2026. The document announced the withdrawal of approval of 15 abbreviated new drug applications (ANDAs) from multiple applicants,…
Source: Federal Register
Acadia Healthcare (ACHC) since this story, compared with the market
Since the first closing price after “Teva Pharmaceuticals USA, Inc., et al.; Withdrawal of Approval of 15 Abbreviated New Drug Applications; Correction,” Acadia Healthcare (ACHC) is +3.28%. The S&P 500 fund (SPY) is -1.36% over the same days, a +4.64% difference versus the market.
Filings that name Acadia Healthcare (ACHC) around 6 Oct 2026
- Gilbert Cisneros sell BridgeBio Pharma (BBIO) ($1,001 - $15,000). That is 7 days before publication, inside 30 days. The filing is listed beside the story “Teva Pharmaceuticals USA, Inc., et al.; Withdrawal of Approval of 15 Abbreviated New Drug Applications; Correction.”
- Rohit Khanna buy GE HealthCare Technologies (GEHC) ($1,001 - $15,000). That is 25 days before publication, inside 30 days. The filing is listed beside the story “Teva Pharmaceuticals USA, Inc., et al.; Withdrawal of Approval of 15 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
For “Teva Pharmaceuticals USA, Inc., et al.; Withdrawal of Approval of 15 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
Ascendis Pharma A/S (ASND) is linked, with no stored direction, medium confidence in the 6 Oct 2026 story “Teva Pharmaceuticals USA, Inc., et al.; Withdrawal of Approval of 15 Abbreviated New Drug Applications; Correction.” 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 “Teva Pharmaceuticals USA, Inc., et al.; Withdrawal of Approval of 15 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
In “Teva Pharmaceuticals USA, Inc., et al.; Withdrawal of Approval of 15 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 6 Oct 2026 story “Teva Pharmaceuticals USA, Inc., et al.; Withdrawal of Approval of 15 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 6 Oct 2026 story “Teva Pharmaceuticals USA, Inc., et al.; Withdrawal of Approval of 15 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)
On 6 Oct 2026, “Teva Pharmaceuticals USA, Inc., et al.; Withdrawal of Approval of 15 Abbreviated New Drug Applications; Correction” is the story that connects Acadia Healthcare (ACHC) to this story.
Acadia Healthcare (ACHC) is on the page because 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
Also listed, Ascendis Pharma A/S (ASND): 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 in the story, and the Acadia Healthcare (ACHC) price range
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.
How strong the case is around Acadia Healthcare (ACHC)
54 out of 100
“Teva Pharmaceuticals USA, Inc., et al.; Withdrawal of Approval of 15 Abbreviated New Drug Applications; Correction” scores 54 out of 100. The score uses 2 sources, and 6 linked companies.