> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Kremers Wants FDA Ordered to Provide ANDA Info
- URL: https://www.fdaweb.com/kremers-wants-fda-ordered-to-provide-anda-info/
- Published: 2017-01-12T12:00:00.000Z
- Updated: 2026-09-14T21:59:50.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137712

Kremers Urban Pharmaceuticals says FDA has ignored two Freedom of Information Act (FOIA) requests for information on its ANDA for extended-release methylphenidate tablets for which the agency says it intends to withdraw approval. The company filed [suit](http://www.fdaweb.com/download.php?file=4959430-0--16608.pdf) in DC district court, saying it received an agency 10/17/16 notice of the proposal to withdraw approval of the ANDA that gave Kremers an opportunity to schedule a hearing on the proposal.

“FDA must provide Kremers with the information that the agency relied on to issue the Notice of Opportunity for Hearing,” the suit says. “Without that information, Kremers will not have a constitutionally adequate opportunity to support its request for a hearing or to prepare for any hearing. The requested information is also important to the public’s understanding of the process.”

The filing says that on 11/7/16 and again on 11/18/16, Kremers filed FOIA requests for records relating to the Notice of Opportunity for Hearing and asked for expedited processing. FDA acknowledged the 11/7 request and then denied the expedited processing, the company’s suit says. Because the agency did not produce any documents, Kremers says it filed the second request 11/18/16, which FDA acknowledged but then did not respond to the request for expedited processing and did not produce any records. At no time has the agency claimed any exemption from disclosure, the suit says.

Kremers says the agency initially set a hearing date for 12/19/16 and then granted an extension to 3/20\. “Even with that extension,” the suit says, “relatively little time remains for Kremers to analyze and respond to the documents and information it seeks through FOIA requests.”

Because FDA failed to make a determination and provide notice of that determination within the statutorily enacted time limits of 20 working days after receiving an FOIA request, the company has exhausted all of its administrative remedies and the court should order FDA to respond, according to the suit.

It asks the court for expedited consideration, a declaratory judgment that FDA has improperly withheld the requested records, a finding that the agency’s failure to comply with its FOIA obligation has harmed Kremers, an order directing FDA to respond and produce the requested documents on an expedited basis, costs and reasonable attorney fees, and any other relief that the court deems appropriate.