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Halfway Through February – OGD on Pace for Ninety Approval Actions

With numbers reported to date through March 15th,  it looks like the OGD will reach ninety approval actions this month.  There have been thirty-eight full approvals and seven tentative approvals reported so far this month.  With the OGD averaging eighty-eight full approvals for the first five months of FY 2019, it will need to push to get to that number by the end of the month,

Particulate Material Back in the News

Over the last two days, the FDA has announced the recall of two products from two different companies (here and here), each due to the presence of particulate matter in the product.  One was confirmed as glass particles and the other as a copper salt (particulates seen at the twelve-month stability station). 

Update on Valsartan “Priority” Review

The FDA’s posting of the approval for the “priority” review ANDA for Valsartan mentioned yesterday (here) occurred today.  The ANDA number was listed as 205536.  It is interesting to note that the ANDA number corresponds to an application that was submitted around the middle of 2013.  That is almost six years! 

FDA Prioritizes ANDA for Valsartan to Avert Shortage

On March 12, 2019, the FDA approved an ANDA for Valsartan “to help relieve the recent shortage of this critical medicine as a result of multiple recalls of generic valsartan products from several manufacturers due to the finding that certain lots of Valsartan and other ARB medicines contain nitrosamine impurities.”  The Agency prioritized the ANDA’s approval but is it not yet clear how quickly the FDA approved the ANDA or when it was submitted as it is not yet listed on the approval site or in the Orange Book.

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Lachman Consultants Returns to ISPE Europe 2019

(Westbury, NY – March 2019) On the heels of establishing a European based presence last year, Lachman Consultant Services, Inc., a leading provider of expert compliance, regulatory affairs, and technical services to life sciences organizations worldwide, will return to the ISPE Europe 2019 Annual Conference. Lachman is sponsoring the event on April 1-4,

Amy Schutte, new Senior Associate, Regulatory at Lachman Consultant Services, Inc.

We are pleased to announce that Amy Schutte has accepted the position of Senior Associate, Regulatory at Lachman Consultants, effective March 28, 2019. She will report to Aloka Srinivasan.

Ms. Schutte is a pharmaceutical industry professional with specialization in Regulatory Affairs and experience in quality, regulatory compliance, and pharmacovigilance. After nearly 20 years in the industry,