Dockets Entered on July 12, 2006

Dockets Management



Dockets Entered On July 12, 2006 Table of Contents



Docket #	Title

2002D-0325	Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate

2002P-0317	Recall Aspartame as a Neurotoxic Drug

2004E-0402	Patent Extension for AVASTIN (bevacizumab), U.S. Patent No. 6,054,297

2005N-0437	Medical Gas Containers and Closures; Current Good Manufacturing

2005P-0411	Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs

2006E-0008	Patent Extension Application for DRAXXIN (tulathromycin), U.S. Patent No. 6,420,536

2006E-0024	Patent Extension Application for VNS Therapy System, U.S. Patent No. 5,299,569

2006E-0204	Patent Extension Application for NATRECOR (nesiritride) for U.S. Patent No. 5,114,923

2006E-0282	Patent Extension Application for Phakic Intraocular Lenses, U.S. Patent No. 5,192,319

2006N-0181	Product Stability Data: Notice of Pilot Project

2006P-0085	To Exempt the Class II device Cranial Orthoses from Premarket Notification Requirements

2006P-0151	Stay the current approvable letter with conditions of any and all Premarket Applications for silicone gel-filled breast implants

2006P-0280	Emergency Request to Open Blood Products Advisory Committee Meeting on Friday, July 14, 2006

2006P-0281	Determination of Orudis KT (ketoprofen, 12.5 mg) Oral Tablet

2002D-0325	Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate
EMC 252	S. Keyser	Vol #:	4

2002P-0317	Recall Aspartame as a Neurotoxic Drug

EMC 671	Mission Possible International	Vol #:	10

EMC 672	Mission Possible International	Vol #:	10

2004E-0402	Patent Extension for AVASTIN (bevacizumab), U.S. Patent No. 6,054,297

LET 4	U.S. Patent and Trademark Office	Vol #:	1

2005N-0437	Medical Gas Containers and Closures; Current Good Manufacturing

EMC 5	Compressed Gas Association (CGA) and Gases and Welding Distributors Association (GAWDA)	Vol #:	3

EMC 6	BOC Gases	Vol #:	3

2005P-0411	Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs

C 15351	J. Longobucco	Vol #:	171

C 15352	P. Harper	Vol #:	171

C 15353	C. Huson	Vol #:	171

C 15354	L. McGuiff	Vol #:	171

C 15355	V. Tiernan	Vol #:	171

C 15356	P. Thomas	Vol #:	171

C 15357	C. Hockett-Prelle	Vol #:	171

C 15358	C. Jones	Vol #:	171



C 15359	J. McKee	Vol #:	171

C 15360	E. Epstein	Vol #:	171

C 15361	F. Burris	Vol #:	171

C 15362	G. Pickering	Vol #:	171

C 15363	S. McFerson	Vol #:	171

C 15364	N. Golden	Vol #:	171

C 15365	M. Hardin	Vol #:	171

C 15366	M. Hardin	Vol #:	171

C 15367	S. Stermer	Vol #:	171

C 15368	Tennessee Pharmacists Association	Vol #:	171

C 15369	M. Marks	Vol #:	171

C 15370	J. Johnson	Vol #:	171

C 15371	B. Silver	Vol #:	171

C 15372	K. Stowe	Vol #:	17

C 15373	D. Sullivan	Vol #:	171

C 15374	J. Keen	Vol #:	171

C 15375	C. Benjamin	Vol #:	171

C 15376	R. Bartsch	Vol #:	171

C 15377	S. Walton	Vol #:	171

C 15378	D. Erickson	Vol #:	171

C 15379	A. Howard	Vol #:	171

C 15380	M. Desjardins	Vol #:	171

C 15381	A. Shumate	Vol #:	171

C 15382	Northampton Wellness Associates, L. L. C.	Vol #:	171

C 15383	C. Moreau	Vol #:	171

C 15384	J. Long	Vol #:	171

C 15385	B. Finucan	Vol #:	171

C 15386	C. Stephens	Vol #:	171

C 15387	L. Kyselka	Vol #:	171

C 15388	G. Taylor	Vol #:	171

C 15389	M. Diamond	Vol #:	171

C 15390	R. Adams	Vol #:	171

C 15391	D. Murphy	Vol #:	171

C 15392	C. Rose	Vol #:	171

C 15393	C. Dremel	Vol #:	171

C 15394	Ms. Scott	Vol #:	171

C 15395	E. Zimmerman	Vol #:	171



C 15396	C. St. Avalos	Vol #:	171

C 15397	T. West	Vol #:	171

C 15398	S. Hughes	Vol #:	171

C 15399	B. Oldfield	Vol #:	171

C 15400	V. Houk	Vol #:	171

C 15401	D. Damico	Vol #:	171

C 15402	L. Ross	Vol #:	171

C 15403	C. Hammack	Vol #:	171

C 15404	P. Parsley	Vol #:	171

C 15405	J. Hart	Vol #:	171

C 15406	B. Moe	Vol #:	171

C 15407	A. Carrasco	Vol #:	171

C 15408	A. Appenzeller	Vol #:	171

C 15409	P. Kennedy	Vol #:	171

C 15410	L. Mahaney	Vol #:	171

C 15411	E. Lannon	Vol #:	171

C 15412	S. Brininstool	Vol #:	171

C 15413	F. Richards	Vol #:	171

C 15414	B. Combs	Vol #:	171

C 15415	L. Henry	Vol #:	171

C 15416	V. Davis	Vol #:	171

C 15417	R. Chapman	Vol #:	171

C 15418	C. Brower	Vol #:	171

C 15419	A. Jeffries	Vol #:	172

C 15420	B. Keller	Vol #:	172

C 15421	K. Fischer	Vol #:	172

C 15422	A. Khalsa	Vol #:	172

C 15423	D. Rau	Vol #:	172

C 15424	S. Fortune	Vol #:	172

C 15425	C. Lee	Vol #:	172

C 15426	J. Sykes	Vol #:	172

C 15427	D. Williamson	Vol #:	172

C 15428	M. Woodward	Vol #:	172

C 15429	J. Janson	Vol #:	172

C 15430	K. Gazecki	Vol #:	172

C 15431	B. Robinette	Vol #:	172

C 15432	T. Herring	Vol #:	172



C 15433	L. Grissom	Vol #:	172

C 15434	M. Woolley	Vol #:	172

C 15435	T. Plahe	Vol #:	172

C 15436	Y. Conrad	Vol #:	172

C 15437	D. Schrepel	Vol #:	172

C 15438	C. Wilhelm	Vol #:	172

C 15439	D. Werkman	Vol #:	172

C 15440	A. Faulkner	Vol #:	172

C 15441	J. Manson	Vol #:	172

C 15442	J. MacLean-Fowler	Vol #:	172

C 15443	K. Law	Vol #:	172

C 15444	T. Spencer	Vol #:	172

C 15445	M. Solomich	Vol #:	172

C 15446	T. Quinlin	Vol #:	172

C 15447	J. Cordon	Vol #:	172

C 15448	A. Moon	Vol #:	172

C 15449	S. Trogdon	Vol #:	172

C 15450	S. Hudson	Vol #:	172

C 15451	C. Bishop	Vol #:	172

C 15452	J. Webb	Vol #:	172

C 15453	B. Jehu	Vol #:	172

C 15454	J. Signorelli	Vol #:	172

C 15455	D. Brooks	Vol #:	172

C 15456	H. Runge	Vol #:	172

C 15457	S. Schafer	Vol #:	172

C 15458	D. Belshee-Storlie	Vol #:	172

C 15459	L. Thompson	Vol #:	172

C 15460	K. Farrer	Vol #:	172

C 15461	B. Manning	Vol #:	172

C 15462	D. Carter	Vol #:	172

C 15463	J. Fabrega	Vol #:	172

C 15464	M. Feicco	Vol #:	172

C 15465	L. Plesse	Vol #:	172

C 15466	L. Motz	Vol #:	172

C 15467	M. Becker	Vol #:	172

C 15468	D. Evans	Vol #:	172

C 15469	D. Evans	Vol #:	172



C 15470	D. Evans	Vol #:	172

C 15471	D. Evans	Vol #:	172

C 15472	J. Nelson	Vol #:	172

C 15473	J. Nelson	Vol #:	172

C 15474	T. McMahon	Vol #:	172

C 15475	J. Tinney	Vol #:	172

C 15476	S. Lauzon	Vol #:	172

C 15477	P. Karsten	Vol #:	172

C 15478	E. Drosiun	Vol #:	172

C 15479	P. McDermott	Vol #:	172

C 15480	K. Elflein	Vol #:	172

C 15481	K. Elflein	Vol #:	172

C 15482	E. Dagroski	Vol #:	172

C 15483	W. Maltz	Vol #:	172

C 15484	M. Londry	Vol #:	172

C 15485	J. Barnes	Vol #:	172

C 15486	M. Schmidt	Vol #:	172

C 15487	L. Kaminer	Vol #:	172

C 15488	M. Walker	Vol #:	172

C 15489	P. Jensen	Vol #:	172

C 15490	D. Moore	Vol #:	172

EC 33248	International Academy of Compounding Pharmacists	Vol #:	142

2006E-0008	Patent Extension Application for DRAXXIN (tulathromycin), U.S. Patent No. 6,420,536

LET 3	U.S. Patent and Trademark Office	Vol #:	1

2006E-0024	Patent Extension Application for VNS Therapy System, U.S. Patent No. 5,299,569

LET 3	U.S. Patent and Trademark Office	Vol #:	1

2006E-0204	Patent Extension Application for NATRECOR (nesiritride) for U.S. Patent No. 5,114,923

LET 3	U.S. Patent and Trademark Office	Vol #:	1

2006E-0282	Patent Extension Application for Phakic Intraocular Lenses, U.S. Patent No. 5,192,319

APP 1	Akerman Senterfitt	Vol #:	1

LET 1	U.S. Patent and Trademark Office	Vol #:	1

LET 2	U.S. Patent and Trademark Office	Vol #:	1

2006N-0181	Product Stability Data: Notice of Pilot Project

LET 2	Genzyme Corporation (Genzyme)	Vol #:	1



2006P-0085	To Exempt the Class II device Cranial Orthoses from Premarket Notification Requirements

CR 1	FDA/DDM to AANS/CNS	Vol #:	1

2006P-0151	Stay the current approvable letter with conditions of any and all Premarket Applications for silicone gel-filled breast implants

EC 619	Ms. Anna Leamon	Vol #:	3

2006P-0280	Emergency Request to Open Blood Products Advisory Committee Meeting on Friday, July 14, 2006

ACK 1	FDA/DDM to Public Citizen Litigation Group	Vol #:	1

CP 1	Public Citizen Litigation Group	Vol #:	1

2006P-0281	Determination of Orudis KT (ketoprofen, 12.5 mg) Oral Tablet

ACK 1	FDA/DDMB to Camargo Pharmaceutical Services, LLC	Vol #:	1

CP 1	Camargo Pharmaceutical Services, LLC	Vol #:	1

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FDA/Dockets Management