USFDA

Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.

Lexicon Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved INPEFA (sotagliflozin), a once-daily oral tablet to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with :
heart failure or
type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors.

The Janssen Pharmaceutical Companies of Johnson & Johnson announced that all three prospective indications for milvexian, an investigational oral factor XIa (FXIa) inhibitor (being developed in collaboration with Bristol Myers Squibb), have now been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA). The designations cover all three indication-seeking studies within the Phase 3 Librexia development program (Librexia STROKE, Librexia ACS and Librexia AF), which are all dosing patients.

The U.S. Food and Drug Administration approved Xacduro (sulbactam for injection; durlobactam for injection), a new treatment for hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) caused by susceptible strains of bacteria called Acinetobacter baumannii-calcoaceticus complex, for patients 18 years of age and older.

the U.S. Food and Drug Administration approved Brixadi (buprenorphine) extended-release injection for subcutaneous use (under the skin) to treat moderate to severe opioid use disorder (OUD). Brixadi is available in two formulations, a weekly injection that can be used in patients who have started treatment with a single dose of a transmucosal buprenorphine product or who are already being treated with buprenorphine, and a monthly version for patients already being treated with buprenorphine.

For the first time, researchers described the structure of a special type of amyloid beta plaque protein associated with Alzheimer’s disease (AD) progression. In a report published May 10 in the journal Neuron, scientists showed the small aggregates of the amyloid beta protein could float through the brain tissue fluid, reaching many brain regions and disrupting local neuron functioning.  The research also provided evidence that a newly approved AD treatment could neutralize these small, diffusible aggregates.

Zydus Lifesciences Limited has received final approval from the United States Food and Drug Administration (USFDA) to manufacture and market Ephedrine Sulfate Injection USP, 50 mg/mL single-dose vials (USRLD: Akovaz® Injection).

Ephedrine Sulfate Injection is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia. The drug will be manufactured at the group’s injectable manufacturing facility at Jarod, near Vadodara (India).

Astellas Pharma Inc. announced that the U.S. Food and Drug Administration (FDA) has approved VEOZAHTM (fezolinetant) 45 mg once daily for the treatment of moderate to severe vasomotor symptoms (VMS) due to menopause1 on May 12. VEOZAH is the first nonhormonal neurokinin 3 (NK3) receptor antagonist approved to treat VMS due to menopause.

Dr. Reddy's Laboratories Ltd. launched Regadenoson Injection in the U.S. market, a generic therapeutic equivalent of Lexiscan (Regadenoson) injection, approved by U.S. Food and Drug Administration (USFDA).

Lexiscan is a registered trademark of Astellas US LLC. It is an A2A adenosine receptor agonist that is a coronary vasodilator that is commonly used in pharmacologic stress testing. It produces hyperemia quickly and maintains it for a duration that is useful for radionuclide myocardial perfusion imaging.