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GSK Withdraws Wellcovorin NDA - Leucovorin Calcium Tablets Discontinued

FDA withdrew approval of NDA 018342 for Wellcovorin (leucovorin calcium) tablets at GSK's written request after the company notified the Agency the drug products were no longer marketed. GSK waived its opportunity for a hearing and requested withdrawal under 21 CFR 314.150(c). Existing inventory may be dispensed until depleted or until expiration dates.

FDA Requirement for Patent Information to Clark & Elbing

FDA Requirement for Patent Information to Clark & Elbing

USPTO Letter to FDA CDER on Patent Matters, Apr 8

USPTO sent an inter-agency letter to FDA CDER regarding patent-related matters. The communication appears in a FDA regulatory docket and addresses coordination between the two agencies on intellectual property issues. No specific regulatory requirements or compliance obligations are detailed in the available documentation.

Letter from USPTO to FDA CDER Regarding Patent Matters

The USPTO sent correspondence to FDA's Center for Drug Evaluation and Research on April 9 regarding patent-related matters. The document is filed under docket FDA-2026-E-3821-0001 and is available only as an attachment PDF on regulations.gov.

Letter to FDA CDER Regarding Patent Matter

USPTO transmitted correspondence to FDA CDER regarding a patent-related matter. The letter is filed under docket FDA-2026-E-3811-0001 and is accessible as a PDF attachment. Specific content details are not visible in the available document metadata.

USPTO Letter to FDA CDER Regarding Patent Procedures

The USPTO transmitted correspondence to FDA's Center for Drug Evaluation and Research regarding patent-related procedures. The letter was filed in the regulatory docket on April 9, 2026. This inter-agency communication addresses administrative patent matters between the two federal agencies.

USPTO Letter to FDA CDER on Patent Matters

The USPTO sent a letter to FDA's Center for Drug Evaluation and Research on April 9, 2026, regarding patent-related matters. The correspondence appears to address inter-agency coordination on pharmaceutical patent issues. No documents are available for public viewing in the regulatory docket.

Milestone Pharma Patent Term Extension Application

FDA received a patent term extension application from Clark & Elbing LLP on behalf of Milestone Pharmaceuticals, Inc. The application seeks to extend patent protection for a drug product regulated by CDER. Patent term restoration may compensate for regulatory review time under applicable law.

Milestone Pharmaceuticals Patent Term Extension Application

Clark & Elbing, LLP filed a patent term extension application on behalf of Milestone Pharmaceuticals, Inc. with the FDA's Center for Drug Evaluation and Research (CDER). The application seeks to extend patent protection for a pharmaceutical product to compensate for regulatory review time. Patent term extensions under 35 U.S.C. 156 can extend patent terms by up to 5 years.

USPTO Letter to FDA CDER Regarding Patent Matters

USPTO sent a letter to FDA CDER regarding patent-related matters. The document contains limited content available for public review, with the full letter available only as an attachment. This represents routine inter-agency communication on intellectual property matters affecting pharmaceutical regulation.