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Baxter Corp.

Division of Baxter International Inc.

Latest From Baxter Corp.

US FDA’s First Competitive Generic Therapy Approval Comes With A Twist

Apotex’s potassium chloride oral solution is eligible for 180-day exclusivity under new expedited pathway even though Amneal’s generic referencing same product was approved three weeks earlier; Amneal's continued marketing will not be blocked by Apotex’s exclusivity, which is forfeited if it fails to launch within 75 days.

Approvals Generic Drugs

US FDA’s First Competitive Generic Therapy Approval Comes With A Twist

Apotex’s potassium chloride oral solution is eligible for 180-day exclusivity under new expedited pathway even though Amneal’s generic referencing same product was approved three weeks earlier; Amneal's continued marketing will not be blocked by Apotex’s exclusivity, which is forfeited if it fails to launch within 75 days.

Approvals Generic Drugs

Saline Bag Shortages Continue As Flu Season Heats Up

The shortage of medical products caused by Hurricane Maria continues even as US FDA moves expiration dates and allows more imports to fill the need.

Medical Device Regulation

Puerto Rico Tax-Haven Status, R&D Credit Weakened By Tax-Reform Bill

Under tax reform legislation recently passed by Congress, a 20% tax on products made in domestic territories will adversely affect the many device firms with Puerto Rican plants that currently enjoy a lower, 4% tax rate on profits. And a second tax provision usually relied upon by medtech companies, the R&D tax credit, also loses ground under the final Senate bill passed Dec. 2.

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