Decisions, Decisions, Decisions! Our Updated Labeling Carve-Out Citizen Petition Scorecard

By Kurt R. Karst –      

A lot has happened since we last updated our Generic Drug Labeling Carve-Out Citizen Petition Scorecard in October 2011.  At that time, AstraZeneca had only recently submitted two citizen petitions concerning quetiapine fumarate (SEROQUEL and SEROQUEL XR).  Petitions, FDA decisions, lawsuits, and court decisions have abounded since.  So we thought it was high time for us to update our popular scorecard and add a few more bells and whistles, such as FDC Act § 505(j)(10) Citizen Petitions and Approval Precedents (see our previous post here for background), and, given the increasing frequency with which FDA issues petition decisions without comment, a section on Non-Response Denials of Labeling Carve-Out Citizen Petitions.  But before you jump down this post to our updated scorecard, let’s take a minute to take stock of the last 7+ months . . . .

FDA has responded to a several labeling carve-out petitions over the last few months.  Some of the responses have been no comment denials, including responses to petitions on generic SEROQUEL and SEROQUEL XR concerning the scope and applicability of 3-year exclusivity.  (In that case, FDA ultimately issued a letter decision explaining how the Agency handled the exclusivity vis-à-vis generics.)  And just last week, FDA denied without comment another petition concerning generic CRESTOR (rosuvastatin calcium) Tablets.  In that response, FDA said that given the status of patent infringement litigation “it is unnecessary for FDA to analyze the precise contours of AstraZeneca’s 3-year exclusivity and its consequences, if any, for the labeling of proposed [ANDA and 505(b)(2) products] at this time.” 

FDA has also issued petition decisions providing the Agency’s initial interpretations of two relatively new provisions of the FDC Act.  First, in denying a petition concerning generic DORYX (doxycycline hyclate) Delayed-Release Tablets, FDA interpreted FDC Act § 505(j)(10), which was added to the statute by Sec. 10609 of the Affordable Care Act (the so-called “generic loophole” provision).  Second, in denying a petition concerning generic VANCOCIN (Vancomycin HCl) Capsules, FDA interpreted the availability of 3-year exclusivity for an “old antibiotic” under FDC Act § 505(v) as added by the 2008 QI Act (see our previous post here). 

FDA’s petition decisions have also ended up in court.  Both before and after approving generic versions of SEROQUEL, AstraZeneca sued FDA (see our previous posts here and here).  The U.S. District Court for the District of Columbia denied AstraZeneca’s Motion for Temporary Restraining Order seeking to vacate FDA’s ANDA approval decisions and to enjoin the future approvals.  On April 11, 2012, FDA filed a Motion to Dismiss the case.  FDA was also sued after approving generic VANCOCIN and denying ViroPharma’s citizen petition.  The D.C. District Court promptly denied ViroPharma’s Motion for a Temporary Restraining Order and/or Preliminary Injunction, and in doing so deferred to FDA’s interpretation of the QI Act (among other things).

Generic Drug Labeling Carve-Out Citizen Petition Scorecard

FDA Citizen Petition Responses 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 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 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)

Pending Labeling Carve-Out Citizen Petitions

• Docket No. FDA-2007-P-0294 – ACTOS (pioglitazone)
• Docket No. FDA-2007-P-0113 – THALOMID (thalidomide)
• 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-2010-P-0403 – VAGIFEM (estradiol)
• Docket No. FDA-2011-P-0482 – VAGIFEM (estradiol)  

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; FDA Letter Decision – SKELAXIN (metaxalone) (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. 1997P-0178 – TORADOL (ketorolac tromethamine)