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FDA Decides Not to Approve Additional Amlodipine ANDAs at This Time
April 18, 2007Earlier today, FDA issued its decision with respect to amlodipine generics and the applicability of Mylan’s 180-day exclusivity and Pfizer’s pediatric exclusivity. The U.S. District Court for the District of Columbia in Mylan v. Leavitt had ordered FDA to respond to Mylan’s TRO motion by April 18, 2007. According to FDA’s notice to the court, “FDA has decided not to approve ANDAs other than Mylan’s at this time.” FDA’s 14-page decision letter accompanying the notice concludes that:
· All of the unapproved ANDAs are currently blocked by Pfizer’s pediatric exclusivity.
· If and when the mandate effectuating the panel’s March 22 decision issues in the Apotex case, Apotex’s ANDA will not be blocked by Pfizer’s pediatric exclusivity.
· FDA cannot determine on the current record whether other ANDAs will continue to be blocked by pediatric exclusivity at this time.
· Mylan’s 180-day marketing exclusivity terminated when the patent expired.
It is unclear at this time what action generic applicants other than Mylan might take to challenge FDA’s decision. We will continue to update you on this developing story.
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- AMG v. FTC: A Moot Court-Worthy Conflict at the Supreme Court January 15, 2021
- Orange Book Modernization Act: Congress Largely Codifies FDA’s Existing Orange Book Practices, But Also Brings PTAB Decisions Into the Fold January 14, 2021
- OTC Monograph Drug User Fees FY2021 (Temporarily?) Off the Table January 11, 2021
- When Will the Emergency End? January 11, 2021
- The Long and Winding Road: DEA Issues Final Marijuana Registration Rule January 8, 2021
- Big Molecule Watch Blog
- Bloomberg BNA Health Care Blog
- Drug and Device Law Blog
- Eye on FDA
- FDA Matters
- Harvard Law Bill of Health
- IN VIVO Blog
- Internet Drug News.com
- Lachman Consultants Blog
- Medical Devices Today
- Orange Book Blog
- The Orange Book Insights Blog
- Pharma IQ
- Pharmalot
- SCOTUS Blog
- The Volokh Conspiracy
- WLF Legal Pulse
- Advertising and Promotion (Federal Trade Commission)
- Advertising and Promotion (OPDP)
- Animal Drugs and Feeds
- Biosimilars
- Cannabis
- cGMP Compliance
- Consumer Product Safety Commission
- Controlled Substances
- Cosmetics
- COVID19
- Current Affairs
- Dietary Supplements
- Drug Development
- Drug Enforcement Administration
- Enforcement
- FDA News
- Foods
- Foods and Dietary Supplements
- Fraud and Abuse
- Government Pricing
- Hatch-Waxman
- Health Care
- Health Privacy
- Import/Export
- In Vitro Diagnostic Devices
- Jobs
- Medical Devices
- Miscellaneous
- Orphan Drugs
- OTC Drugs and Cosmetics
- Prescription Drugs and Biologics
- Product Jurisdiction and Combination Products
- Reimbursement
- Tissue Products
- Tobacco
- Uncategorized