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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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- FDA in the Multiverse of 180-Day Exclusivity Madness: Is an “Incursion” in the Cards for our “Exclusivity Earth-616”? May 26, 2022
- A New Report Takes an Evidence-Based Approach to Analyzing the BLOCKING Act May 25, 2022
- FDA Issues Safety Warning Regarding Non-Invasive Prenatal Testing Raising Questions About the Future of FDA Regulation of LDTs May 25, 2022
- FDA Issues Flurry of Warning Letters Regarding Adulterated Dietary Supplements May 24, 2022
- HP&M’s Sara Koblitz to Present at DC Bar’s FDA for IP Lawyers Webinar May 23, 2022
- 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