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Lead Product(s): Diltiazem Hydrochloride
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Undisclosed
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 23, 2021
Details:
The approved diltiazem hydrochloride extended-release capsules USP, 60 mg, 90 mg, and 120 mg is the generic version of Cardizem SR extended-release capsules, 60 mg, 90 mg, and 120 mg, of Biovail Laboratories Inc.
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Lead Product(s): Midodrine
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Undisclosed
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 22, 2021
Details:
The US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Midodrine Hydrochloride Tablets USP, 2.5 mg, 5 mg, and 10 mg.
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Lead Product(s): Atenolol,Chlorthalidone
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Undisclosed
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 28, 2020
Details:
Atenolol and Chlorthalidone Tablets are indicated for the treatment of hypertension, to lower blood pressure. The product will be commercialized from Unichem’s Ghaziabad Plant.
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Lead Product(s): Ethacrynic Acid
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Undisclosed
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 20, 2020
Details:
Strides Pharma Global Pte. Limited, Singapore, has received approval for Ethacrynic Acid Tablets USP, 25 mg from the United States Food & Drug Administration (USFDA). The product is a generic version of Edecrin® Tablets, 25 mg, of Bausch Health Americas, Inc.
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Lead Product(s): Apixaban
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Undisclosed
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 14, 2020
Details:
Apixaban is an anticoagulant, or blood thinner. It is used for patients with health problems caused by a blood clot.
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Lead Product(s): Ivabradine Hydrochloride
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Undisclosed
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 02, 2020
Details:
Approval marks the first once-a-day formulation for Ivabradine in India, which will help increase adherence to therapy for chronic heart failure and chronic stable angina.
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Lead Product(s): Midodrine
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Undisclosed
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 02, 2020
Details:
Zydus Cadila has received final approval from the USFDA to market Cisatracurium Besylate Injection USP (US RLD: Nimbex ®) in the strength of 20 mg (base)/10 mL (2 mg/mL) Multiple-Dose Vial.
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