Approvals

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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24
Feb
October Approvals

Glimpses of What’s Ahead – FY 2019 GDUFA Science and Research Report

The FDA issued its Fiscal Year (FY) GDUFA Science and Research Report last week (read the full report here and the awarded research contracts and grants here).  A review of the innovative scientific focus areas helps those of us in the industry to get a sense of where the FDA is headed in support of […]

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18
Feb
Budget friendly health brands

When It Rains, It Pours; Recent Rx-to-OTC Switches

February 14, 2020 could be called a red letter day in the world of Rx-to-OTC switch.  After a long period of drought, FDA announced that they have approved the Rx-to-OTC switch of three prescription drugs. Please see the announcement here.  The three drugs are: Voltaren Arthritis Pain (diclofenac sodium topical gel, 1%) for the temporary […]

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