Bausch Health US LLC

Alembic Pharmaceuticals has secured Final Approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Diltiazem Hydrochloride Extended-Release Capsules USP, 120 mg, 180 mg, 240 mg, 300 mg, and 360 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Cardizem CD Extended-Release Capsules, 120 mg, 180 mg, 240 mg, 300 mg, and 360 mg, of Bausch Health US, LLC. Diltiazem Hydrochloride Extended-Release Capsules USP are indicated for the treatment of hypertension. Diltiazem hydrochloride may be used alone or in combination with other antihypertensive medications. It is also indicated for the management of chronic stable angina and angina due to coronary artery spasm. Refer label for a detailed indication. Diltiazem Hydrochloride Extended-Release Capsules USP, 120 mg, 180 mg, 240 mg, 300 mg, and 360 mg have an estimated market size of USD 105.3 million for twelve months ending June 2024 according to IQVIA. Alembic has a cumulative total of 218 ANDA approvals (191 final approvals and 27 tentative approvals) from USFDA.

Mumbai: Alembic Pharmaceuticals Limited (Alembic) announced that it has received final approval from the US Food & Drug Administration (US FDA) for its abbreviated new drug application (ANDA) for Diltiazem Hydrochloride Extended-Release Capsules USP, 120 mg, 180 mg, 240 mg, 300 mg, and 360 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Cardizem CD Extended-Release Capsules , 120 mg, 180 mg, 240 mg, 300 mg, and 360 mg, of Bausch Health US, LLC. Diltiazem Hydrochloride Extended-Release Capsules USP are indicated for the treatment of hypertension. Diltiazem hydrochloride may be used alone or in combination with other antihypertensive medications. It is also indicated for the management of chronic stable angina and angina due to coronary artery spasm. Refer label for a detailed indication. Diltiazem Hydrochloride Extended-Release Capsules USP, 120 mg, 180 mg, 240 mg, 300 mg, and 360 mg have an estimated market size of US $105.3 million for twelve months ending June 2024 according to IQVIA. By Online Bureau ,

Represents the Company’s ninth product launch since inception in October 2023 Avenacy to offer Isoproterenol Hydrochloride Injection, USP in the market-preferred vial presentation SCHAUMBURG, Ill.--(BUSINESS WIRE)-- Avenacy, a specialty pharmaceutical company focused on supplying critical injectable medications, today announced it has launched Isoproterenol Hydrochloride Injection, USP in the United States as a therapeutic generic equivalent for ISUPREL® as approved by the U.S. Food and Drug Administration. Isoproterenol Hydrochloride Injection, USP is indicated: This press release features multimedia. View the full release here: (Photo: Business Wire) For mild or transient episodes of heart block that do not require electric shock or pacemaker therapy. For serious episodes of heart block and Adams-Stokes attacks (except when caused by ventricular tachycardia or fibrillation). For use in cardiac arrest until electric shock or pacemaker therapy, the treatments of choice, is available. For bronchospasm occurring during anesthesia. As an adjunct to fluid and electrolyte replacement therapy and the use of other drugs and procedures in the treatment of hypovolemic and septic shock, low cardiac output (hypoperfusion) states, congestive heart failure, and cardiogenic shock. Avenacy's Isoproterenol Hydrochloride Injection, USP is available in 0.2 mg/mL and 1 mg/5 mL 10-pack single-dose vials. In line with Avenacy’s mission to champion patient safety and streamline patient care, Isoproterenol Hydrochloride Injection, USP will feature the Company’s highly differentiated packaging and labeling to support accurate medication selection. Avenacy will begin shipping Isoproterenol Hydrochloride Injection, USP to wholesale partners this week. The Company is supported by a global network of development and contract manufacturing partners that have undergone successful FDA inspections based on cGMP-standards. Isoproterenol Hydrochloride Injection, USP had U.S. sales of approximately $26 million for the twelve months ending in June 2023.1 Please see link for Full Prescribing Information. ISUPREL® is a registered trademark of Bausch Health US, LLC. 1Source: IQVIA About Avenacy Avenacy is a U.S.-based specialty pharmaceutical company focused on supplying critical injectable medications used to treat patients in various medically supervised settings, from acute care hospitals to outpatient clinics and physician offices. Through a rigorous and optimized selection process, the Company is building out a pipeline of high-quality FDA approved injectable products in order to ensure a resilient portfolio that can meet the needs of today’s dynamic drug supply chain. With an experienced team, commitment to quality and reliability, and product offerings intended to facilitate safe and efficient patient care, Avenacy strives to be a trusted partner for essential medications. Avenacy was launched in 2023 and is headquartered in Schaumburg, IL. For more information, please visit .