The 15 approvals for the generic of Cialis come on the day of the expirations of the 180-day exclusivity enjoyed by the first-to-file applicants. Assuring that the ANDAs gain approval on the first legally possible date that they can be approved means that the price will go down and, when 15 ANDAs receive approval, the price decrease should be substantial.
As many dietary supplement marketers are essentially virtual companies, all manufacturing and testing is performed by organizations contracted by the marketer. In the ten years or so since the dietary supplement GMPs went into effect, control of these contractors has been an ongoing challenge. Most dietary supplement marketers have demonstrated adequate control over their contractors,
This morning the FDA released a guidance document entitled Pediatric Information Incorporated Into Human Prescription Drug and Biological Product Labeling (here) which provides direction to firms that are developing labeling for pediatric patients based on findings of required or literature studies or data that are either positive, negative or inconclusive.
Coauthored by Kurt Karst (of FDA Law Blog) and Bob Pollock
The “Petitioned ANDA”—It’s a route to ANDA approval that’s been around since even before the enactment of the 1984 Hatch-Waxman Amendments. For several years after the enactment of Hatch‑Waxman, the petitioned ANDA was a mainstay of the generic drug industry’s drug development paradigm.
Every day, when I look at the ANDA approvals list, I see that most of the approvals are for the older ANDAs that were submitted to OGD before Year 4 of GDUFA I (when goal dates started). Some of these applications are anywhere from six to ten years old. Once they receive approval, they have a “negative trend” on the mean and median time to approval reported by the FDA.
(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,
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,
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,
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).
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!
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.
A federal judge entered a consent decree to a 503A compounder of sterile drug products in Texas. According to the FDA News Release (here), the compounding facility received repeated warnings from the FDA over a two‑year period but continued to compound sterile ophthalmic products. “The government alleges that Guardian manufactured and distributed purportedly sterile drug products that were adulterated because the drugs were made under insanitary conditions and in violation of current good manufacturing practice requirements under the FD&C Act.
On Thursday, March 7, the FDA published a draft supplementary guidance on non-proprietary naming of biological products <here>, which updates the January 2017 Final Guidance on Nonproprietary Naming of Biological Products <here>. Both of these guidance documents address the FDA’s requirement for including a four-letter nonsense suffix in the proper name for biological products.
Timothy Rhines, Ph.D. is a Director in the Science & Technology Practice at Lachman Consultants who is a seasoned CMC pharmaceutical / biopharmaceutical professional with more than 27 years directing CMC activities, leading analytical chemistry teams, addressing compliance gaps, compliance department leadership with P&L responsibility, implementing process excellence initiatives, developing pharmaceutical product stability operations, and CMC project management.
Each year, the OGD publishes a list of first-time generic approvals, which are defined by the agency as:
“First generics” are just what they sound like—the first approval by the FDA which permits a manufacturer to market a generic drug product in the United States. The FDA considers first generics to be important to public health and prioritizes review of these submissions.