01
May
Warning sign

Black Box Warning Added to Singulair and Montelukast Generics Labeling

The FDA has added a Black Box warning to the popular drug montelukast (brand name Singulair).  A black box warning is one of FDA’s most significant label warnings, and in this case, there are recommendations to potentially change therapeutic decisions based on the severity of the diseases and the potential risk benefit The new warning […]

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27
Jan

Competitive Generic Therapy Approvals Listed by FDA

The FDA has provided a list of all products approved under the Competitive Generic Therapy (CGT) designation program under section 506H of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This exclusivity is awarded for products with limited generic competition and provides for a potential 180-day exclusivity marketing period. On its current list (here), […]

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27
Jan

Scott Deckebach, M.B.A., new Director in the Compliance Practice at Lachman Consultant Services, Inc.

We are pleased to announce that Scott Deckebach has accepted the position of Director in the Compliance Practice at Lachman Consultants, effective January 27, 2020. Mr. Deckebach is a life sciences and medical device regulatory compliance, manufacturing, and technology expert with more than 25 years of experience in the industry. Mr. Deckebach has been affiliated […]

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22
Jan
Terrified businessman with crystal ball

Two-Thirds of the Way through January, Approval Action Totals Signal A Below-Average Month

With seven of twenty-two business days left in the month, the OGD stands at twenty-seven full‑approval actions and seven tentative‑approval actions.  The FY 2020 average for each category so far is just under fifty‑eight full‑approval actions and twelve tentative‑approval actions.  Unless the end of the month picks up, we could see the slowest month for […]

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14
Jan

FDA Evaluating Diet Drug Risks for Increase in Cancer Rates

In a January 14, 2020 Drug Safety Communication (here), FDA discusses an alert to patients taking the weight loss drugs Belviq or Belviq XR (lorcaserin) of a potential increase in the risk of cancer.  The NDA drug products were approved on July 27, 2012 (immediate-release) and July 15, 2016 (extended-release version), respectively. The Agency notes […]

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08
Jan

FDA Publishes List of 249 ANDAs it Proposes to Withdraw

In the Federal Register pre-publication notices today, the FDA announced an opportunity for hearing for 249 ANDAs that it proposes to withdraw because the applicants have repeatedly failed to submit Annual Reports.  The notice announces the opportunity for a hearing for any of the applicants.  Many of the ANDAs are old applications, with some from […]

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08
Jan
OGD Updates Additional Metrics In March Stats Image

OGD Updates November 2019 Metrics

Today is January 8th and the OGD just updated the November 2019 metrics (here) with the following information of interest: the OGD refused-to-receive three ANDAs (all of which were standard applications) and acknowledged fifty-five original ANDAs. There were twenty ANDAs withdrawn in November (two were approved ANDAs that were likely no longer marketed) and eighteen […]

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