Search Results for Marketing Exclusivity

Showing 1 – 5

Marketing Exclusivity for Over-the-Counter Switched Products By Deborah Livornese - Published 19 December 2017

This article discusses the regulatory process for changing a drug's status from "prescription only" to Over-the-Counter (OTC) and discusses issues related to gaining exclusivity for OTC switched products under FDA regulations and guidance and Congressional legislation.

Categories: Features, FDA, Over the counter drugs, Prescription drugs

Tags: OTC Switch, Marketing Exclusivity

House Bill Would Incentivize Drugmakers to 'Repurpose' Drugs for Rare Diseases By Michael Mezher - Published 02 March 2017

Rep. Gus Bilirakis (R-FL) on Monday reintroduced a bill that would grant drugmakers an additional six months exclusivity for repurposing already-approved drugs to treat rare diseases.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Government affairs, Orphan products, Submission and registration

Tags: OPEN Act, Marketing Exclusivity,

FDA’s Approval of a New Abuse-Deterrent Opioid Raises Questions By Zachary Brennan - Published 10 January 2017

The US Food and Drug Administration (FDA) on Monday raised some eyebrows with its approval of another long-acting opioid, Egalet’s Arymo ER (morphine sulfate extended-release tablets), with abuse-deterrent properties.

Categories: News, US, FDA, Drugs, Regulatory intelligence, Regulatory strategy

Tags: opioid, opioid abuse, marketing exclusivity, FDA drug approval, abuse-deterrent opioid

Senators Call for 15 Years of Marketing Exclusivity for Some New Drugs Published 12 December 2014

Two US senators have proposed new legislation that would grant an unprecedented 15 years of marketing exclusivity to certain types of pharmaceutical and biopharmaceutical products.

Categories: News, US, CDER, Biologics and biotechnology, Drugs

Tags: MODDERN Cures Act, Marketing Exclusivity, Senate, Congress, Bill, Legislation, Dormant Therapies Act

Orphan Drug Marketing Exclusivity Revoked from Product as FDA Admits Error By Alexander Gaffney - Published 10 August 2012

Categories: FDA

Tags: Revoked, Marketing Exclusivity, FVIII, Humate, Wilate, CSL Behring, Octapharma, Latest News, orphan drug