The Generic Drug Labeling Carve-Out Scorecard

By Kurt R. Karst –      

With the recent litigation surrounding FDA’s approval of ANDAs for generic versions of PRECEDEX (dexmedetomidine HCl) Injection – which litigation has now moved on to Motions for Summary Judgment (see our updates here for the latest briefs) – we’ve had renewed interest in (and requests to update) our popular Generic Drug Labeling Carve-Out Scorecard (a.k.a. the Labeling Carve-Out Citizen Petition Scorecard).  We last updated that scorecard more than two years ago (see here), and we promised to make it a static feature of the FDA Law Blog home page last September when we introduced our Biosimilars State Legislation Scorecard (which also needs to be updated).  So much to do; so little time. . . .  But we found a few minutes to finally draft this post and make a permanent home for the Generic Drug Labeling Carve-Out Scorecard.

This version of the scorecard adds several new FDA decisions (either as a response to a citizen petition, or from an FDA letter decision outside of the petitioning process) and some new (and still pending) citizen petitions. 

Enjoy the scorecard!  And if you're aware of anything you think we missed, then please let us know and we'll take a look and decide whether or not to update the scorecard accordingly.  We note that sometimes determining whether or not a citizen petition submitted to FDA is really about a labeling carve-out issue can be difficult to discern.  Take, for example, a recent citizen petition concerning ProAir HFA (albuterol sulfate) Inhalation Aerosol (Docket No. FDA-2014-P-0404), which FDA responded to late last week.  While the petition does raise, among other things, the issue of 3-year exclusivity eligibility and the effects on generics, that petition is more about the scope of 3-year exclusivity than ANDA labeling carve-outs.  Thus, we would not include a petition like that on our scorecard.

FDA Citizen Petition Responses & Letter Decisions Permitting a Labeling Carve-Out

• FDA Response, Docket Nos. 2001P-0495, 2002P-0191, FDA-2002-P-0003 (June 11, 2002) – ULTRAM (tramadol HCl)
• FDA Response, Docket Nos. 2001P-0495/PRC, 2002P-0191/PRC, FDA-2002-P-0003/PRC (Mar. 31, 2003) – ULTRAM (tramadol HCl)
• FDA Response, Docket No. FDA-2003-P-0074 (Apr. 6, 2004) – REBETOL (ribavirin)
• FDA Letter Decision (Mar 1, 2004) - SKELAXIN (metaxalone) Tablets
• FDA Response, Docket No. FDA-2005-P-0368 (Dec. 1, 2006) – OXANDRIN (oxandrolone)
• FDA Response, Docket No. FDA-2006-P-0274 (Mar. 13, 2008) – ETHYOL (amifostine)
• FDA Response, Docket No. FDA-2007-P-0169 (Apr. 25, 2008) – MARINOL (dronabinol)
• FDA Response, Docket No. FDA-2008-P-0304 (June 18, 2008) – ALTACE (ramipril)
• FDA Response, Docket No. FDA-2008-P-0069 (July 28, 2008) – CAMPTOSAR (irinotecan HCl)
• FDA Response, Docket No. FDA-2006-P-0073 (Nov. 18, 2008) – PULMICORT Respules (budesonide inhalation suspension)
• FDA Response, Docket Nos. FDA-2008-P-0343 & FDA-2008-P-0411 (Dec. 4, 2008) – PRANDIN (repaglinide)
• FDA Response, Docket No. FDA-2008-P-0343/PRC and PSA & FDA-2008-P-0411 (June 16, 2009) – PRANDIN (repaglinide)
• FDA Response, Docket No. FDA-2009-P-0411 – ACTOS (pioglitazone HCl) & ACTOPLUS MET (March 15, 2010) (pioglitazone HCl; metformin HCl)
• FDA Response, Docket No. FDA-2009-P-0601 (June 17, 2010) – NAROPIN (ropivacaine HCl monohydrate)
• FDA Response, Docket No. FDA-2010-P-0087 (July 30, 2010) – LYRICA (pregabalin) 
• FDA Response, Docket No. FDA-2010-P-0545 (Feb. 24, 2011) – XYZAL (levocetirizine dihydrochloride)
• FDA Response, Docket No. FDA-2011-P-0128 (May 11, 2011) – XIBROM/BROMDAY (bromfenac)
• FDA Response, Docket No. FDA-2011-P-0702 (Feb. 8, 2012) – DORYX (doxycycline hyclate)
• FDA Letter Decision, Related to Docket Nos. FDA-2011-P-0662 & FDA-2011-P-0663 (Mar. 27, 2012) – SEROQUEL (quetiapine fumarate)
• FDA Response, Docket No. FDA-2006-P-0007 (Apr. 9, 2012) – VANCOCIN (Vancomycin HCl) Capsules
• FDA Response, Docket No. FDA-2012-P-1018 (Feb. 15, 2013) – COLCRYS (colchicine) Tablets
• FDA Response, Docket No. FDA-2013-P-0247 (Aug. 1, 2013) – RECLAST (zoledronic acid) Injection
• FDA Response, Docket No. FDA-2013-P-1293 (Mar. 10, 2014) – REMODULIN (treprostinil) Injection
• FDA Letter Decision, Docket No. FDA-2014-N-0087 (Aug. 18, 2014) – PRECEDEX (dexmedetomidine HCl) Injection

FDA Citizen Petition Responses Not Permitting a Labeling Carve-Out

• FDA Response, Docket No. FDA-2003-P-0002 (Sept. 20, 2004) – RAPAMUNE (sirolimus)
• FDA Response, Docket No. FDA-2010-P-0614 (May 25, 2011) – COLCRYS (colchicine) Tablets

Pending Labeling Carve-Out Citizen Petitions

• Docket No. FDA-2007-P-0294 – ACTOS (pioglitazone)
• Docket No. FDA-2009-P-0581 – BAYTRIL (enrofloxacin) (Animal Drug)
• Docket No. FDA-2009-P-0597 – Fluticasone Propionate and/or Salmeterol Xinafoate Products
• Docket No. FDA-2011-P-0482 – VAGIFEM (estradiol) Tablets 
• Docket No. FDA-2012-P-0632 – COLCRYS (colchicine) Tablets  
• Docket No. FDA-2014-P-1649 – FUSILEV (levoleucovorin) for Injection

Non-Response Denials of Labeling Carve-Out Citizen Petitions

• FDA Response, Docket No. FDA-2011-P-0662 (Mar. 7, 2012) – SEROQUEL (quetiapine fumarate)
• FDA Response, Docket No. FDA-2011-P-0663 (Mar. 7, 2012) – SEROQUEL XR (quetiapine fumarate) 
• FDA Response, Docket No. FDA-2011-P-0823 (May 11, 2012) – CRESTOR (rosuvastatin calcium)

BPCA Section 11 Pediatric Labeling Citizen Petitions

• FDA Response, Docket No. FDA-2001-P-0053 (January 24, 2002) – BPCA Implementation
• FDA Response, Docket No. FDA-2002-P-0289 (May 21, 2003) – ALPHAGAN (brimonidine)
• FDA Response, Docket No. FDA-2010-P-0545 (February 24, 2011) – XYZAL (levocetirizine dihydrochloride) 

FDC Act § 505(j)(10) Citizen Petitions and Approval Precedents

• FDA Response, Docket No. FDA-2011-P-0702 (Feb. 8, 2012) – DORYX (doxycycline hyclate) Delayed-Release Tablets
• ANDA No. 076786, Donepezil Hydrochloride Tablets, 5 mg and 10 mg
• ANDA No. 078388, Donepezil Hydrochloride Orally-Disintegrating Tablets, 5 mg, and 10 mg
• ANDA No. 077431, Exemestane Tablets, 25 mg
• ANDA No. 076361, Levofloxacin Tablets, 250 mg, 500 mg, and 750 mg
• ANDA No. 077179, Amlodipine besylate and Benazepril HCl Capsules, 5 mg (base)/40 mg and 10 mg (base)/40 mg

Moot/Withdrawn/“Dead” Labeling Carve-Out Citizen Petitions

• Docket Nos. FDA-2004-P-0426, FDA-2003-P-0081, & 2001P-0481 - SKELAXIN (metaxalone) Tablets; FDA Letter Decision – SKELAXIN (metaxalone) Tablets (see our previous post here)
• Docket No. FDA-2001-P-0445 – NEURONTIN (gabapentin) Capsules
• Docket No. FDA-2005-P-0368 (Petition for Reconsideration; Dec. 5, 2006) – OXANDRIN (oxandrolone)
• Docket No. FDA-1997-P-0034 (Legacy FDA Docket No. 1997P-0178) – TORADOL (ketorolac tromethamine)
• Docket No. FDA-2007-P-0113 – THALOMID (thalidomide); FDA Response (Sept. 30, 2014)
• Docket No. FDA-2010-P-0403 – VAGIFEM (estradiol) Tablets