Philip Katz

Assisted a client in developing FDA legal and regulatory strategy for obtaining approval and three-year exclusivity that was essential to commercial success.
Developed and implemented a strategy that convinced FDA to reverse its denial of orphan drug designation for a company’s sole product and moved the product to approval and orphan drug exclusivity.
Represented Depomed at FDA and in court to obtain orphan exclusivity for Gralise.
Represented a senior executive in negotiating and operating under an FDA consent decree and subsequent Department of Justice investigation.
Authored a successful FDA petition ensuring patent certification and opportunity for litigation and 30-month stay with competitor’s 505(b)(2) NDA.
Successfully advocated to the FDA Exclusivity Board for favorable decision on the scope of three-year exclusivity.
Advised senior management on developing and implementing an NDA resubmission strategy after a Complete Response Letter.
Represented a reference listed drug sponsor in negotiating shared REMS with a generic competitor and advocating at the FDA on related issues.
Advised an overseas manufacturer on responding to Form FDA 483 inspectional observations and subsequent Import Alert.
Advised a company on FDA strategy for approval of first product, responded to competitor petitions and interacted with underwriters in an IPO.

Band 1: Pharmaceutical/Medical Products Regulatory: Washington, D.C. –
Chambers USA
Band 3: Life Sciences: Regulatory/Compliance: Nationwide –
Chambers USA
Band 3: Life Sciences: Regulatory/Compliance (USA) –
Chambers Global
Leading Practitioner: FDA: Pharmaceuticals –
LMG Life Sciences
Recommended for Healthcare: Life Sciences –
Legal 500 US
FDA Law:
Best Lawyers in America
Distinguished Service and Leadership Award: Food and Drug Law Institute

Philip KatzPhilipKatz