Drug Industry Daily
July 8, 2013
The FDA has determined that UCB did not discontinue Metadate ER for safety and effectiveness reasons, paving the way for generic versions of the attention deficit/hyperactivity disorder (ADHD) drug.
The decision, published in a Wednesday Federal Register notice, could lead to more extended-release generics on the market -- a category of drugs that has caused the agency headaches before.
The FDA is paying closer attention to extended-release generics after Impax and Teva withdrew their 300-mg Wellbutrin XL generic last year because it wasn't therapeutically equivalent to the branded drug. At the time, the agency said it wants to improve its methods for studying extended-release products, including evaluating its bioequivalence policies for certain drugs.
In November 2011, UCB told the FDA it was discontinuing Metadate ER (methylphenidate HCl) extended-release tablet, 10 mg, citing limited demand for the dosage, spokeswoman Kristie Madara told DID Wednesday. She said the company still manufactures Metadate ER in a 20 mg dose.
A March 2013 citizen's petition filed by Tedor Pharma asked the FDA to look into that decision and confirm that it wasn't for safety and effectiveness reasons.
The agency reviewed data from postmarketing adverse events and files and records concerning the withdrawal, according to the Federal Register notice.
The FDA found "no information" that indicates the product, originally approved in 1999, had to be dropped because of safety or effectiveness, the notice states.
Since the drug was discontinued for marketing reasons, the FDA said it will accept ANDA applications for generic versions.
Tedor did not return a request for comment as of press time.
To read the Federal Register notice, visit www.fdanews.com/ext/files/07-3-13-MetadateDecision.pdf.
The FDA has determined that UCB did not discontinue Metadate ER for safety and effectiveness reasons, paving the way for generic versions of the attention deficit/hyperactivity disorder (ADHD) drug.
The decision, published in a Wednesday Federal Register notice, could lead to more extended-release generics on the market -- a category of drugs that has caused the agency headaches before.
The FDA is paying closer attention to extended-release generics after Impax and Teva withdrew their 300-mg Wellbutrin XL generic last year because it wasn't therapeutically equivalent to the branded drug. At the time, the agency said it wants to improve its methods for studying extended-release products, including evaluating its bioequivalence policies for certain drugs.
In November 2011, UCB told the FDA it was discontinuing Metadate ER (methylphenidate HCl) extended-release tablet, 10 mg, citing limited demand for the dosage, spokeswoman Kristie Madara told DID Wednesday. She said the company still manufactures Metadate ER in a 20 mg dose.
A March 2013 citizen's petition filed by Tedor Pharma asked the FDA to look into that decision and confirm that it wasn't for safety and effectiveness reasons.
The agency reviewed data from postmarketing adverse events and files and records concerning the withdrawal, according to the Federal Register notice.
The FDA found "no information" that indicates the product, originally approved in 1999, had to be dropped because of safety or effectiveness, the notice states.
Since the drug was discontinued for marketing reasons, the FDA said it will accept ANDA applications for generic versions.
Tedor did not return a request for comment as of press time.
To read the Federal Register notice, visit www.fdanews.com/ext/files/07-3-13-MetadateDecision.pdf.