New Pregnancy Drug Labeling Rules Take Effect (white paper)

New pregnancy labeling rules for prescription drugs took effect, June 30, 2015, marking the demise of the pregnancy categories (A, B, C, D, X), in use since 1979. The new rule ushers in what is expected to be an unprecedented era of inclusion regarding descriptive risk and benefit information. According to FDA, “a narrative structure…

Proposed Generic Drug Labeling “CBE” Rule Turned on its “EAR”?

Changes Being Effected (CBE) As pharmaceutical consultants, PDG has reported extensively on FDA’s Proposed Rule entitled Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. We even gave it our own abbreviated name: the “Generic CBE Rule”. We did so because the rule as originally proposed would allow generic manufacturers to implement safety…

US Pharmaceutical Consultant on India’s Pharmaceutical Industry and the Decline of the Patent Cliff

India’s Pharma Industry Faces Unprecedented Challenges  India’s pharmaceutical industry has grown at record levels in recent years but now faces unprecedented challenges as the number of blockbuster drugs scheduled to go off patent begins to decline. As Indian pharma has expanded ANDA filings in line with the patent expiration cycles over the last decade, the…

PDG: A Pharmaceutical Consultant on Drug Reformulations

PDG: A Pharmaceutical Consultant on Drug Reformulation

As a pharmaceutical consultant, PDG understands that today’s drug manufacturers rely upon reformulation to prolong product lifecycles, protect against generic competition, supplement dwindling pipelines and otherwise differentiate/repurpose existing drug products. Indeed, novel formulations and drug delivery-based product development strategies have the potential of yielding higher returns on investment than comparable repositioning strategies. The Value of…

Rx-to-OTC Switches Represent Huge Market Potential

Rx-to-OTC switches and the related repositioning of pharmaceutical products from prescription (Rx) dispensing to the retail (over-the-counter or OTC) drug space represent huge market potential. A Strong Domestic OTC Market The U.S. market for OTCs more than doubled between 2007 and 2013 growing from $16 billion to $33 billion. [1] By the beginning of 2014,…

505(b)(2) NDAs

Combination Drug Development and Five Year New Chemical Entity (NCE) Exclusivity

FDA recently announced that Fixed-Combination Drugs (FCD) comprised of at least one NCE will be eligible for 5 years of exclusivity. [1] FDA explained that it has revised its interpretation of the term “drug” for the purpose of exclusivity eligibility from “drug product” to “drug substance”. Therefore, the 5-year NCE exclusivity determination will apply to…

Investigational New Drug Application (IND)/Special Protocol Assessment (SPA)

FDA Delays Publication of Generic Drug CBE Rule Until Fall 2015

In a move that was not entirely unexpected, FDA delayed publication of a rule proposed last year that would allow generic drug sponsors to update safety warnings using the changes being effected (CBE) process. While the comment period had earlier been extended, there was no corresponding extension in the scheduled publication date of December 2014.…

RAPS Reports Generic Drug Industry Threatens FDA With Lawsuit Over Drug Labeling Proposal

PDG™ is a pharmaceutical consultant serving drug sponsors around the world. On July 28, 2014, PDG™ published a chronology of events related to FDA’s proposed rule that would allow generics to use the CBE process to update their labeling with new safety information. Subsequently, RAPS Regulatory Focus (Alexander Gaffney, RAC, October 7, 2014) reported that…

AB Rating 505b2 NDA Generic

FDA Grants AB Rating to 505b2 NDA Generic

FDA recently granted a therapeutic equivalence (TE) rating of AB to a “generic” version of an innovator product approved via a 505b2 NDA.  In July 2014, FDA granted the AB rating to Perrigo’s 1% testosterone gel drug product (NDA 203098) approved in January 2013, and a BX rating to Teva’s (NDA 202763) approved in February 2012. …

Generic Pharmacovigilance/Safety Surveillance and CBEs

Generic Pharmacovigilance/Safety Surveillance & CBEs

As pharmaceutical consultants, PDG devotes considerable resources to both brand & generic drug safety surveillance and labeling issues.  As such, we have followed with great interest the proposed rule entitled “Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products.”  For ease of reference, we’re going to begin to refer to it as the…