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Find Clinical Drug Pipeline Developments & Deals for Asasantin
CAPSULE;ORAL - 356.4MG;30MG;16MG, TABLET;ORAL - 325MG;50MG;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE;ORAL - 325MG;50MG;40MG;30MG, TABLET, DELAYED RELEASE;ORAL - 325MG;40MG, TABLET, DELAYED RELEASE;ORAL - 81MG;40MG, TABLET;ORAL - 250MG;250MG;65MG, CAPSULE, EXTENDED RELEASE;ORAL - 25MG;200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 325MG;50MG;40MG
The US Food & Drug Administration (US FDA) has approved Abbreviated New Drug Application (ANDA) for Acetaminophen, Aspirin and Caffeine Tablets USP, 250 mg/250 mg/65 mg (OTC).
Xarelto (rivaroxaban) is an orally bioavailable factor Xa inhibitor and does not require a cofactor (such as Anti-thrombin III) for activity. Activation of factor X to factor Xa via the intrinsic and extrinsic pathways plays a central role in blood coagulation.
The polypill includes three drugs (aspirin, an ACE inhibitor, and a statin), is effective at preventing secondary adverse cardiovascular events in people who have previously had a heart attack.
Rivaroxaban is the most broadly indicated non-vitamin K antagonist oral anticoagulant (NOAC) worldwide and is marketed under the brand name Xarelto. Xarelto is approved for more venous and arterial thromboembolic (VAT) conditions.
VAZALORE is an FDA-approved liquid-filled aspirin capsule, available in 81 mg and 325 mg doses. VAZALORE delivers aspirin differently from plain and enteric coated aspirin products.
COMPASS open label extension study results support the long-term use of XARELTO (rivaroxaban) plus aspirin for vascular protection in patients with chronic CAD and/or PAD.
Results from the extension part of the COMPASS study support the long-term use of Xarelto (rivaroxaban) plus aspirin for vascular protection in patients with chronic coronary artery disease (CAD) and/or peripheral artery disease (PAD).
Hyloris will use the net proceeds of the Offering primarily to fund the development of new products and accelerate in-house R&D activities including HY-073 (IV acetylsalicylic acid).
Data from the two analyses demonstrate the role that the Xarelto® vascular dose plays in PAD patients with and without chronic kidney disease (CKD) and in PAD patients with and without a history of statin therapy.
Hyloris currently envisages using the net proceeds of the offering to primarily fund the development of additional new product candidates including HY-073 and accelerate in-house R&D activities, including repurposing and analytical expertise.