Dr. Reddy’s Seeks Partner For Norvasc Salt, Says Pfizer Will Not Delay Launch
Executive Summary
Dr. Reddy's is seeking a marketing partner to help promote amlodipine maleate upon FDA approval of the pending 505(b)(2) submission, CEO G.V. Prasad told investors during a June 2 conference call
You may also be interested in...
FDA 505(b)(2) Policy Affirmed; Any Changes Will Be Too Late For Norvasc
FDA will reconsider whether approval of new salt formulations under the Sec. 505(b)(2) process is appropriate, but any changes will not prevent approval of a pending competitor to Pfizer's antihypertensive Norvasc
FDA 505(b)(2) Policy Affirmed; Any Changes Will Be Too Late For Norvasc
FDA will reconsider whether approval of new salt formulations under the Sec. 505(b)(2) process is appropriate, but any changes will not prevent approval of a pending competitor to Pfizer's antihypertensive Norvasc
Pfizer Norvasc Patent: Will Court Limit Extension To “Approved” Product?
Dr. Reddy's reliance on Norvasc data in its 505(b)(2) application for amlodipine maleate could impact an appeals court's determination of whether Pfizer's patent term extension applies only to the approved besylate salt form of the drug