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Only a few of the hundreds of pediatric studies done on marketed drugs have resulted in labeling changes, according to House lawmakers who contend pharmaceutical companies are abusing the six-month pediatric exclusivity provision under federal drug law.
Mylan Pharmaceuticals has sued the FDA over its decision to grant Johnson & Johnson’s (J&J’s) subsidiary Janssen Pharmaceutica six months of pediatric exclusivity on its lucrative pain drug patch Duragesic — a move that will delay generic entry until January 2005.
The FDA’s decision last week to reject Barr Pharmaceutical’s bid for OTC status for its Plan B emergency oral contraceptive was based on scientific analysis of the data, and not political pressure from the White House or Congress, according to a top FDA official.
The FDA has referred Elan Pharmaceuticals’ Zonegran, GlaxoSmithKline’s (GSK) Wellbutrin and Zyban and GelTex Pharmaceuticals’ Renagel to the Foundation for the National Institutes of Health (NIH) for pediatric studies that potentially could lead to new labeling for relevant pediatric populations.
Generic firm Mylan Pharmaceuticals will be able to launch a version of Johnson & Johnson’s (J&J’s) pain drug patch Duragesic (fentanyl) when the patent expires July 23 as long as it meets the requirements of its abbreviated new drug application, the FDA said yesterday.
Generic firm Mylan Pharmaceuticals says Johnson & Johnson’s subsidiary Alza is not entitled to six months of pediatric exclusivity on its pain drug patch Duragesic (fentanyl) because the firm failed to sue Mylan for patent infringement within the required 45-day notification period.
In a move to block generic competition by an additional six months, Bristol-Myers Squibb (BMS) March 31 filed data with the FDA from two clinical studies involving the pediatric use of its profitable cancer drug Paraplatin (carboplatin).
Bristol-Myers Squibb (BMS) has filed data with the FDA from two clinical studies involving the pediatric use of its profitable cancer drug Paraplatin (carboplatin). The move was aimed at avoiding generic competition by an additional six months, the company said last week.