24
Jun

Any Interest in Homeopathic Drugs? 34,341 Comments Suggests So!

The Lachman Blog has posted numerous writings on the issue of homeopathic drugs over the years that we have been publishing this blog.  The most recent post on this topic was on June 17, 2020 (here).  That post spoke about regulatory action taken against four manufacturers of homeopathic drugs in the form of Warning Letters.  […]

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22
Jun
FDA Updates

FDA Updates List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic

The Agency has provided an updated list of drug products that are off-patent and have no unexpired period of market exclusivity and have no generic product approved.  The revised list contains a 2-part listing and an appendix. Part 1 contains 269 targets products for “those drug products for which FDA could immediately accept an ANDA […]

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18
Jun
Pattern obtained by superimposing black numbers on multicolored background. This is obtained by multiple colors paint watercolor technique on paper.

ERRATA for JUNE 16, 2020 POST* – OGD Updates April 2020 Stats and Reports Official May 2020 Approvals, CRLs, and New ANDA Receipts

The Office of Generic Drugs (OGD) updated its April stats and notes 4 refuse-to-receive (RTR) actions (3 standard ANDAs and 1 priority application) which is in line with what we have seen so far this entire FY (months average for 7 months is 3.6 RTRs/month).  OGD also acknowledged 65 new ANDAs in April. Of the […]

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17
Jun

FDA Appears to Be Signaling That They May Be Getting Closer to Regulating Homeopathic Drugs

Based on a news release titled, “FDA Warns Four Manufacturers of Unapproved Injectable Drugs Labeled as Homeopathic Drugs Pose Significant Risks to Patient Health and Violate Federal Law”, the Agency may be getting prepared to tackle regulation of the homeopathic drug market.  In the release, the FDA announces that it issued Warning Letters to four […]

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15
Jun

FDA Revokes Emergency Use Authorization for Chloroquine Phosphate and Hydroxychloroquine Sulfate

In an FDA new release (here), the Agency announced that it was pulling its EUA saying they “determined that the legal criteria for issuing an EUA are no longer met”.  The Agency took this action after a review of the current state of knowledge on the two drugs relative to their unproven efficacy and serious […]

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11
Jun

Process MaPP for Conversion of Approved ANDA to TA after Finding of Patent Infringement

Today, the FDA posted MaPP 5220.2 (here), which outlines a little-known process (because it so seldom happens) that describes how the Agency will go about converting an ANDA approval to a tentative approval (TA).  The issue only occurs when a patent challenge is won by the innovator after the expiration of the thirty-month stay and […]

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