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Pharmaceutical Approvals Monthly


Pharmaceutical Approvals Monthly has merged with “The Pink Sheet”; new material, including the FDA Performance Tracker charts, appears at ThePinkSheet.com. Archived content is available here.

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Message From The Editor: Experience The Transformation/Starting in April, Pharmaceutical Approvals Monthly will be merging with "The Pink Sheet" - with new improved versions of your favorite features, all in one comprehensive source for pharmaceutical intelligence./"Pharmaceutical Approvals Monthly" March 17 2015 4:05 PM

Current Issue:  March 2015

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Drug Review Profile

FDA Aimed For Level Playing Field With Ofev, Esbriet Labeling / The agency tried not to give a marketing advantage to either Boehringer Ingelheim's Ofev or Roche subsidiary InterMune's Esbriet when it simultaneously approved the first two drugs for idiopathic pulmonary fibrosis. / Pharmaceutical Approvals Monthly March 17 2015 11:30 AM

Esbriet And Ofev Reviewers / FDA staff who participated in the review of InterMune’s Esbriet (pirfenidone) and Boehringer Ingelheim’s Ofev (nintedanib) for treatment of idiopathic pulmonary fibrosis. / Pharmaceutical Approvals Monthly March 17 2015 12:45 PM

Esbriet Clinical Development / A timeline chronicling the development of InterMune's idiopathic pulmonary fibrosis treatment pirfenidone. / Pharmaceutical Approvals Monthly March 17 2015 11:50 AM

Ofev Clinical Development / A timeline chronicling the development of Boehringer Ingelheim's idiopathic pulmonary fibrosis drug nintedanib. / Pharmaceutical Approvals Monthly March 17 2015 11:50 AM

FDA Performance Tracker

Estimated FDA User Fee Review Goals For Pending NDAs/BLAs / User fee goals are calculated based on the date of receipt. For applications submitted Oct. 1, 2012 and later, the timeframes are extended two months, to 12 months for standard review new molecular entitites and novel biologic entities and eight months for priority review NMEs and NBEs. / Pharmaceutical Approvals Monthly March 17 2015 4:30 PM

‘Complete Response’ Letters / FDA stopped issuing “approvable” and “not approvable” letters in favor of “complete response” letters on Aug. 11, 2008. The following chart lists “complete response” actions recently announced, as well as still-pending “approvable” and “not approvable” actions. / Pharmaceutical Approvals Monthly March 17 2015 4:05 PM

FDA ‘Breakthrough Therapy’ Designations / Breakthrough status was introduced in FDASIA to facilitate development and review of drugs to treat serious/life-threatening diseases where there is early evidence of a substantial improvement over existing therapies. / Pharmaceutical Approvals Monthly March 17 2015 3:55 PM

FDA Qualified Infectious Disease Product Designations / Qualified Infectious Disease Product Designation was introduced in 2012 as a provision of the FDA Safety and Innovation Act to encourage development of treatments for serious or life-threatening infections caused by bacteria or fungi. / Pharmaceutical Approvals Monthly March 17 2015 1:25 PM

2015 FDA Advisory Committee Recommendations / Year-to-date tracking of drug review recommendations from FDA advisory panels, including regulatory actions. / Pharmaceutical Approvals Monthly March 17 2015 3:55 PM

New Molecular Entities Approved In 2015 / Annual listing of novel drugs cleared by FDA’s Center for Drug Evaluation and Research. / Pharmaceutical Approvals Monthly March 17 2015 1:15 PM

Biologics Approved In 2015 / FDA transferred review of most therapeutic biologics to the Center for Drug Evaluation & Research in 2003. The Center for Biologics Evaluation & Research continues to review other biologics, including vaccines, cellular products, antitoxins and immunoglobulins. / Pharmaceutical Approvals Monthly March 17 2015 1:30 PM

February Full Approvals / Original approvals of NDAs and BLAs. / Pharmaceutical Approvals Monthly March 17 2015 1:15 PM

February ANDA Approvals / Full and tentative generic drug approvals by FDA. / Pharmaceutical Approvals Monthly March 18 2015 10:25 AM

Regulatory Policy

Next Steps for Patient-Centered Drug Development: Room for More Input, With Limits / Patient advocates are pushing FDA to take the next step in the agency’s patient-focused drug development initiative and more directly incorporate the patient experience into regulatory decisions. While that’s a welcomed ask, FDA officials say, it’s not as easy as it looks. / Pharmaceutical Approvals Monthly March 17 2015 12:30 PM

FDA Breast Cancer Patient Meeting Likely To Examine Differences Between Early Stage And Metastatic Experiences / In April, FDA’s patient focused drug development initiative will look at one of the most emotionally and politically fraught areas of advocacy: breast cancer. Here’s a look at what the agency is likely to hear. / Pharmaceutical Approvals Monthly March 17 2015 12:35 PM

FDA ‘Expedited Review’ Would Shave Off Additional Month For Some ‘Breakthrough’ Products / FDA appears to be establishing new regulatory paradigm – albeit one that is not laid out in statute officially. / Pharmaceutical Approvals Monthly March 17 2015 1:10 PM

Testosterone Products Need Post-Market Cardiovascular Trial / Labeling updates will also clarify approved uses and warn of possible increased risk of heart attack and stroke; impact on products in development unclear. / Pharmaceutical Approvals Monthly March 17 2015 12:40 PM

R&D News

Acadia Manufacturing Growing Pains Delay Pimavanserin NDA A Second Time / Company says delay is due to manufacturing scale-up work and does not reflect any change in Parkinson’s psychosis drug’s efficacy or safety profile. In tandem with the news, CEO Hacksell retired, replaced on interim basis by CFO Davis. / Pharmaceutical Approvals Monthly March 17 2015 12:20 PM

AcelRx Baffled By Zalviso Trial Request On Opioid Dispensing Problems / FDA asked for clinical study before reviewing data AcelRx generated after previous ‘complete response,’ CEO King said. / Pharmaceutical Approvals Monthly March 17 2015 12:40 PM

Boehringer Files Pradaxa Antidote, Could Lead To Reversible Novel Anticoagulant / Finishing off a rolling BLA, company believes that the specific antidote for its novel anticoagulant Pradaxa will be eligible for accelerated approval based on Phase I data in volunteers. / Pharmaceutical Approvals Monthly March 17 2015 12:45 PM

Lilly’s Lantus Rival Sidelined By Safety Concerns / Lilly will delay regulatory filing plans for its novel long-acting basal insulin peglispro (BIL) until at least after 2016 as it generates additional clinical data to better understand the effect on the liver. / Pharmaceutical Approvals Monthly March 17 2015 12:45 PM

Pacira’s Exparel Problems: ‘Complete Response’ Letter Stops New Indication / FDA finds issues with a supplemental application to use the pain treatment for nerve block months after warning the company about Exparel marketing. / Pharmaceutical Approvals Monthly March 17 2015 12:40 PM

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