FDA Approval for NALOXONE HYDROCHLORIDE issued to AMPHASTAR PHARMS INC

3/8/23 11:23:02 AM ET

$AMPH

Biotechnology: Pharmaceutical Preparations

Health Care

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New Drug Application (NDA): 208969
Company: AMPHASTAR PHARMS INC

Products on NDA 208969

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NALOXONE HYDROCHLORIDE	NALOXONE HYDROCHLORIDE	4MG/0.25ML	SPRAY;NASAL	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 208969

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/07/2023	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD		Label is not available on this site.

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Recent Analyst Ratings for
$AMPH

Date	Price Target	Rating	Analyst
3/5/2024	$60.00	Overweight	JP Morgan
11/17/2023	$63.00	Neutral	BofA Securities
7/25/2023	$70.00	Buy	Jefferies
10/21/2022	$36.00	Buy	Jefferies
7/29/2022	$44.00	Overweight	CapitalOne
3/11/2022	$28.00 → $35.00	Overweight	Piper Sandler
1/7/2022	$21.00 → $28.00	Neutral → Overweight	Piper Sandler

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$AMPH
Press Releases

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Amphastar Pharmaceuticals Reports Financial Results for the Three Months Ended September 30, 2024
Reports Net Revenues of $191.2 Million for the Three Months Ended September 30, 2024RANCHO CUCAMONGA, CA / ACCESSWIRE / November 6, 2024 / Amphastar Pharmaceuticals, Inc. (NASDAQ:AMPH) ("Amphastar" or the "Company") today reported results for the three months ended September 30, 2024.Third quarter HighlightsNet revenues of $191.2 million for the third quarterGAAP net income of $40.4 million, or $0.78 per share, for the third quarterAdjusted non-GAAP net income of $49.6 million, or $0.96 per share, for the third quarterDr. Jack Zhang, Amphastar's President and Chief Executive Officer, commented: "Amphastar has continued its growth this quarter, highlighted by sales, particularly from BAQSIMI®
11/6/24 4:05:00 PM ET
$AMPH
Biotechnology: Pharmaceutical Preparations
Health Care
Amphastar Pharmaceuticals to Release Third Quarter Earnings and Hold Conference Call on November 6, 2024
RANCHO CUCAMONGA, CA / ACCESSWIRE / October 29, 2024 / Amphastar Pharmaceuticals, Inc. (NASDAQ:AMPH) announced that the Company will release results for its third quarter of 2024 ended September 30, 2024, after the market closes on Wednesday, November 6, 2024, and will hold a conference call to discuss its financial results at 2:00 p.m. Pacific Time.To access the conference call, dial toll free 877-407-0989, for international calls, dial 201-389-0921, ten minutes before the conference.The call can also be accessed on the Investors page on the Company's website www.amphastar.com. The webcast replay of the call will be available on our Company website within 24 hours after the end of the live
10/29/24 6:00:00 AM ET
$AMPH
Biotechnology: Pharmaceutical Preparations
Health Care
Amphastar Pharmaceuticals to Present at the 2024 Wells Fargo Healthcare Conference
RANCHO CUCAMONGA, CA / ACCESSWIRE / August 28, 2024 / Amphastar Pharmaceuticals, Inc. (NASDAQ:AMPH) announced today that Bill Peters, CFO, and Tony Marrs, EVP of Regulatory Affairs and Clinical Operations, will participate in a fireside chat at the 2024 Wells Fargo Healthcare Conference on Thursday, September 5, 2024 at 10:15 am EST. For access, visit Amphastar's Pharmaceuticals website at http://ir.amphastar.com. This webcast will be available for 30 days following the presentation.About Amphastar:Amphastar is a biopharmaceutical company that focuses primarily on developing, manufacturing, marketing, and selling technically-challenging generic and proprietary injectable, inhalation, and int
8/28/24 4:10:00 PM ET
$AMPH
Biotechnology: Pharmaceutical Preparations
Health Care

$AMPH
Financials

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Amphastar Pharmaceuticals Reports Financial Results for the Three Months Ended September 30, 2024
Reports Net Revenues of $191.2 Million for the Three Months Ended September 30, 2024RANCHO CUCAMONGA, CA / ACCESSWIRE / November 6, 2024 / Amphastar Pharmaceuticals, Inc. (NASDAQ:AMPH) ("Amphastar" or the "Company") today reported results for the three months ended September 30, 2024.Third quarter HighlightsNet revenues of $191.2 million for the third quarterGAAP net income of $40.4 million, or $0.78 per share, for the third quarterAdjusted non-GAAP net income of $49.6 million, or $0.96 per share, for the third quarterDr. Jack Zhang, Amphastar's President and Chief Executive Officer, commented: "Amphastar has continued its growth this quarter, highlighted by sales, particularly from BAQSIMI®
11/6/24 4:05:00 PM ET
$AMPH
Biotechnology: Pharmaceutical Preparations
Health Care
Amphastar Pharmaceuticals to Release Third Quarter Earnings and Hold Conference Call on November 6, 2024
RANCHO CUCAMONGA, CA / ACCESSWIRE / October 29, 2024 / Amphastar Pharmaceuticals, Inc. (NASDAQ:AMPH) announced that the Company will release results for its third quarter of 2024 ended September 30, 2024, after the market closes on Wednesday, November 6, 2024, and will hold a conference call to discuss its financial results at 2:00 p.m. Pacific Time.To access the conference call, dial toll free 877-407-0989, for international calls, dial 201-389-0921, ten minutes before the conference.The call can also be accessed on the Investors page on the Company's website www.amphastar.com. The webcast replay of the call will be available on our Company website within 24 hours after the end of the live
10/29/24 6:00:00 AM ET
$AMPH
Biotechnology: Pharmaceutical Preparations
Health Care
Amphastar Pharmaceuticals to Present at the 2024 Wells Fargo Healthcare Conference
RANCHO CUCAMONGA, CA / ACCESSWIRE / August 28, 2024 / Amphastar Pharmaceuticals, Inc. (NASDAQ:AMPH) announced today that Bill Peters, CFO, and Tony Marrs, EVP of Regulatory Affairs and Clinical Operations, will participate in a fireside chat at the 2024 Wells Fargo Healthcare Conference on Thursday, September 5, 2024 at 10:15 am EST. For access, visit Amphastar's Pharmaceuticals website at http://ir.amphastar.com. This webcast will be available for 30 days following the presentation.About Amphastar:Amphastar is a biopharmaceutical company that focuses primarily on developing, manufacturing, marketing, and selling technically-challenging generic and proprietary injectable, inhalation, and int
8/28/24 4:10:00 PM ET
$AMPH
Biotechnology: Pharmaceutical Preparations
Health Care

FDA Approval for NALOXONE HYDROCHLORIDE issued to AMPHASTAR PHARMS INC

Products on NDA 208969

Approval Date(s) and History, Letters, Labels, Reviews for NDA 208969

Original Approvals or Tentative Approvals

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Recent Analyst Ratings for $AMPH

$AMPH Analyst Ratings

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JP Morgan initiated coverage on Amphastar Pharmaceuticals with a new price target

BofA Securities initiated coverage on Amphastar Pharmaceuticals with a new price target

Jefferies resumed coverage on Amphastar Pharmaceuticals with a new price target

$AMPH Insider Trading

Insider transactions reveal critical sentiment about the company from key stakeholders. See them live in this feed.

EVP CORP ADMIN CENTER Liawatidewi Yakob sold $271,389 worth of shares (5,214 units at $52.05) and exercised 5,214 shares at a strike of $13.03 (SEC Form 4)

CFO, EVP & TREASURER Peters William J exercised 7,426 shares at a strike of $13.03 and sold $386,523 worth of shares (7,426 units at $52.05) (SEC Form 4)

SENIOR EVP, PRODUCTION CENTER Zhou Rong exercised 3,000 units of Common Srock at a strike of $14.95 and sold $144,784 worth of Common Srock (3,000 units at $48.26) (SEC Form 4)

$AMPH Press Releases

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Amphastar Pharmaceuticals Reports Financial Results for the Three Months Ended September 30, 2024

Amphastar Pharmaceuticals to Release Third Quarter Earnings and Hold Conference Call on November 6, 2024

Amphastar Pharmaceuticals to Present at the 2024 Wells Fargo Healthcare Conference

$AMPH SEC Filings

SEC Form 10-Q filed by Amphastar Pharmaceuticals Inc.

SEC Form 144 filed by Amphastar Pharmaceuticals Inc.

Amphastar Pharmaceuticals Inc. filed SEC Form 8-K: Results of Operations and Financial Condition, Financial Statements and Exhibits

$AMPH Large Ownership Changes

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$AMPH Market Insights

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SEC Form SC 13G/A filed by Amphastar Pharmaceuticals Inc. (Amendment)

SEC Form SC 13G/A filed by Amphastar Pharmaceuticals Inc. (Amendment)

SEC Form SC 13G/A filed by Amphastar Pharmaceuticals Inc. (Amendment)

Piper Sandler Reiterates Overweight on Amphastar Pharma, Maintains $71 Price Target

Amphastar Pharmaceuticals Authorized A $50M Increase To The Company's Share Buyback Program

Needham Reiterates Hold on Amphastar Pharma

$AMPH Financials

Live finance-specific insights

Amphastar Pharmaceuticals Reports Financial Results for the Three Months Ended September 30, 2024

Amphastar Pharmaceuticals to Release Third Quarter Earnings and Hold Conference Call on November 6, 2024

Amphastar Pharmaceuticals to Present at the 2024 Wells Fargo Healthcare Conference

$AMPH FDA approvals

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FDA Approval for NALOXONE HYDROCHLORIDE issued to AMPHASTAR PHARMS INC

Recent Analyst Ratings for
$AMPH

$AMPH
Analyst Ratings

$AMPH
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$AMPH
Press Releases

$AMPH
SEC Filings

$AMPH
Large Ownership Changes

$AMPH
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$AMPH
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FDA approvals