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