LACHMAN CONSULTANT SERVICES, INC STEWART AVENUE, WESTBURY, NY (516) " FAX (516) $,7,1 OVERNIGHT COURIER 11/16/09

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1 LACHMAN CONSULTANT SERVICES, INC. CONSULTANTS TO THE PHARMACEUTICAL AND ALLIED INDUSTRIES 1600 STEWART AVENUE, WESTBURY, NY (516) " FAX (516) $,7,1 November 16, 2009 OVERNIGHT COURIER 11/16/09 Food and Drug Administration Department of Health and Human Services 5630 Fishers Lane, Room 1061 Rockville, MD Dear Sir or Madam : CITIZEN PETITION The undersigned submits this Citizen Petition pursuant to the Federal Food, Drug, and Cosmetic Act ("FDC Act") and the Food and Drug Administration's ("FDA's") regulations at 21 C.F.R (a), 10.30, and to request that FDA amend the Anproved Drug Products with Therageutic Eguivalence Evaluations ("Orange Book") to designate the Over-the-Counter ("OTC") drug VISINE-A (naphazoline HCI, 0.025% ; pheniramine maleate, 0.3%) Eye Drops as a second Reference-Listed Drug ("RLD"). VISINE-A Eye Drops is listed in the "OTC Drug Product List" section of the Orange Book. The product currently designated as the RLD is NAPHCON-A (naphazoline HCl, 0.025% ; pheniramine maleate, 0.3%) Eye Drops. A. ACTION REQUESTED The undersigned requests that FDA designate VISINE-A Eye Drops as a second RLD for purposes of submitting an Abbreviated New Drug Application ("ANDA") for a generic version of this product. B. STATEMENT OF GROUNDS FDC Act 505(j) allows the marketing of generic versions of previously approved drug products when the generic drug product is the subject of an ANDA. To obtain ANDA approval, the application sponsor must show, among other things, that with respect to a listed drug (i.e., a previously approved drug product), the generic drug product has the same active ingredient(s) in the same strength, has essentially identical labeling, and is bioequivalent. A "listed drug" is a new drug product that has an effective approval under FDC Act 505(c) for safety and effectiveness or under section FDC Act 505(j), that has not been withdrawn or suspended under FDC Act 505(e)(I) through (5) or (j)(5), and that has not been withdrawn from sale for reasons of safety or effectiveness. See 21 C.F.R Listed drugs are identified in FDA's Orange Book. An RLD is the listed drug identified by FDA as the drug product on which ANDA applicants should rely in seeking approval of their applications. See id. ~ ~~ -P-oSs7 LCS@lachmanconsultants.com

2 LACHMAN CONSULTANT SERVICES, INC. Westbury, NY Food & Drug Administration November 16, 2009 Page 2 of 3 FDA stated its policy for designating a second RLD in the preamble to the Agency's 1992 final ANDA Regulations. Specifically, in response to comments asking FDA to explain how the Agency determines which drugs should be RLDs, FDA stated :... FDA will designate [RLDs]. Generally, the [RLD] will be the NDA drug product for a single source drug product. For multiple source NDA drug products or multiple source drug products without an NDA, the [RLD] generally will be the market leader as determined by FDA on the basis of commercial data. FDA recognizes that, for multiple source products, a product not designated as the listed drug and not shown bioequivalent to the listed drug may be shielded from direct generic competition. If an applicant believes that there are sound reasons for designating another drug as a [RLD], it should consult FDA. FDA, Final Rule, ANDA Regulations, 57 Fed. Reg. 17,950, 17,958 (Apr. 28, 1992) (emphasis added). The Orange Book Preface also states : [I]n some instances when listed drugs are approved for a single drug product, a product not designated as the [RLD] and not shown to be bioequivalent to the [RLD] may be shielded from generic competition. A firm wishing to market a generic version of a listed drug that is not designated as the [RLD] may petition the Agency through the Citizen Petition procedure... When the Citizen Petition is approved, the second listed drug will be designated as an additional [RLD] and the petitioner may submit an [ANDA] citing the designated [RLD]. Orange Book Preface (29th Ed.) at x. There is a sound basis for designating VISINE-A Eye Drops as an RLD. The current annual edition of the Orange Book identifies two New Drug Application ("NDA") approved drug products containing naphazoline HCI and pheniramine maleate in the same strengths, dosage form, and route of administration (i.e., pharmaceutical equivalents) : (1) NDA No (NAPHCON-A Eye Drops) ; and (2) NDA No (VISINE-A Eye Drops). See Orange Book (29th Ed.) at FDA designated NAPHCON-A Eye Drops as the RLD, which is identified with the symbol "+" in the Orange Book. Drug products included in the "OTC Drug Product List" section of the Orange Book are not assigned therapeutic equivalence ratings ; however, we understand that FDA does not consider NAPHCON-A Eye Drops and VISINE-A Eye Drops to be interchangeable. Unless FDA designates VISINE-A Eye Drops (NDA No ) as an RLD, a generic applicant planning to submit an application must identify NAPHCON-A Eye Drops (NDA No ) as the RLD. This effectively shields VISINE-A Eye Drops from generic competition and supports FDA designating VISINE-A Eye Drops as an RLD. C. ENVIRONMENTAL IMPACT Pursuant to 21 C.F.R , an environmental impact statement is not required for this action because the grant of the Citizen Petition would not have an effect on the environment. D. ECONOMIC IMPACT Information on the economic impact of the action requested by this Citizen Petition will be submitted if requested by FDA. wwnu.lachmanconsultants.com LCS@lachmanconsultants.com

3 LACHMAN CONSULTANT SERVICES, INC. Westbury, NY 115" Food & Drug Administration November 16, 2009 Page 3 of 3 E. CERTIFICATION The undersigned certifies that, to the best knowledge and belief of the undersigned, this petition includes all information and views upon which the Petition relies, and that it includes representative data and information known to the Petitioner which is unfavorable to the Petition. Respectfully skbmitted, Robert W. Pollock Executive Vice President RP/pk Attachment : Orange Book cc : Martin Shimer, Office of Generic Drugs, FDA P07P9320 unuuw.lachmanconsultants.com LCMachmanconsultants.com

4 Orpge Book Detail Record Search Page 1 of 1 Search results from the "013-OTC" table for query on " " Active Ingredient: NAPHAZOLINE HYDROCHLORIDE ; PHENIRAMINE MALEATE Dosage Form;Route : SOLUTION/DROPS ; OPHTHALMIC Proprietary Name : VISINE-A Applicant : JOHNSON AND JOHNSON Strength : 0.025% ;0.3% Application Number : Product Number: 001 Approval Date : Jan 31, 1996 Reference Listed Drug No RX/OTC/D I SC N : OTC Patent and Exclusivity Info for this product : View Return_ta Electronic_ Orange_Book_Home Page FDA/Center for Drug Evaluation and Research Office of Generic Drugs Division of Labeling and Program Support Update Frequency: Orange Book Data - Monthly Generic Drug Product Information & Patent Information - Daily Orange Book Data Updated Through September, 2009 Patent and Generic Drug Product Data Last Updated : November 13, No=020485&TA... 11/16/2009

5 Or~tnge Book Detail Record Search Page 1 of 1 Search results from the "OB OTC" table for query on " " Active Ingredient : Dosage Form;Route : Proprietary Name : Applicant : Strength : Application Number : Product Number: Approval Date : Reference Listed Drug RX/OTC/DISCN : Yes OTC Patent and Exclusivity Info for this product : View NAPHAZOLINE HYDROCHLORIDE ; SOLUTION/DROPS ; OPHTHALMIC NAPHCON-A ALCON 0.025% ;0.3% Jun 8, 1994 PHENIRAMINE MALEATE Return to.electronic Orange..Book _Home_Page FDA/Center for Drug Evaluation and Research Office of Generic Drugs Division of Labeling and Program Support Update Frequency: Orange Book Data - Monthly Generic Drug Product Information & Patent Information - Daily Orange Book Data Updated Through September, 2009 Patent and Generic Drug Product Data Last Updated : November 13, /16/2009

6 Page 1 of 2 From: Origin ID: RMFJ4 (516)6a1881 Westbury Office LACHMAN CONSULTANT SERVICES 1600 STEWART AVE SUITE 604 WESTBURY, NY SHIP T0 : (301) BILL SENDER Food and Drug Administration 5630 FISHERS LN RM 1061 HHS, HFA-305 ROCKVILLE, MD f f' f IKE1 IE Ship Date: 16NOV09 AclWgt 0.5 LB CAD: NET9090 Accounl#: S """"""""" Delivery Address Bar Code II~YIIIIIIIIIIIIIIIIIIIIIIIIINIIIIII Ref# Documents from LCS TUE-17NOV A2 TRK# STANDARD OVERNIGHT DSR ZD i OBTA ii r ri~r I riw MD-US IAD After printing this label : 1. Use the 'Print' button on this page to print your label to your laser or inkjet printer. 2. Fold the printed page along the horizontal line. 3. Place label in shipping pouch and affix it to your shipment so that the barcode portion of the label can be read and scanned. Warning : Use only the printed original label for shipping. Using a photocopy of this label for shipping purposes is fraudulent and could result in additional billing charges, along with the cancellation of your FedEx account number. Use of this system constitutes your agreement to the service conditions in the current FedEx Service Guide, available on fedex.com.fedex will not be responsible for any claim in excess of $100 per package, whether the result of loss, damage, delay, non-delivery,misdelivery,or misinformation, unless you declare a higher value, pay an additional charge, document your actual loss and file a timely claim.limitations found in the current FedEx Service Guide apply. Your right to recover from FedEx for any loss, including intrinsic valueof the package, loss of sales, income interest, profit, attorney's fees, costs, and other forms of damage whether direct, incidental,consequen6al, or special is limited to the greater of $100 or the authorized declared value. Recovery cannot exceed actual documented Ioss.Maximum for items of extraordinary value is $500, e.g. jewelry, precious metals, negotiable instruments and other items listed in our ServiceGuide. Written claims must be filed within strict time limits, see current FedEx Service Guide. 11/16/2009