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DEPARTMENT OF HXALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Rockville MD 20857 JUN 1 9 2003 . 3085 '03 JiJN20 A942 Ms. Patricia Jaworksi IVAX Pharmaceuticals, Inc. 140 Legrand Avenue Northvale, NJ 07647 Re: Docket No. 02P-0391/ CP 1 Dear Ms. Jaworski: This letter responds to your citizen petition dated August 30, 2002, requesting that the Food and Drug Administration (FDA) determine whether brimonidine tartrate ophthalmic solution 0.2% (Alphagan 0.2%) was withdrawn from sale for reasons of safety or effectiveness. FDA has reviewed its records and has determined that brimonidine tartrate ophthalmic solution 0.2% (Alphagan 0.2%) was not withdrawn from sale for reasons of safety or effectiveness. Accordingly, FDA will continue to list brimonidine tartrate ophthalmic solution 0.2% in the “Discontinued Drug Product List” section of Approved Drug Products With Therapeutic Equivalence Evaluations (the Orange Book). Enclosed is a copy of the Federal Register notice announcing FDA’s determination. If you require any further information, please call me at (301) 594-2041. Sincerely yours, Aileen H. Ciampa Office of Regulatory Policy Center for Drug Evaluation and Research Enclosure . 34980 Federal RegisterlVol. authority, FDA participates with State regulatory agencies, some foreign nations, and the molluscan shellfish industry in the National Shellfish Sanitation Program (NSSP). The NSSP is a voluntary, cooperative program to promote the safety of molluscan shellfish by providing for the classification and patrol of shellfish growing waters and for the inspection and certification of shellfish processors. Each participating State and foreign nation monitors its molluscan shellfish processors and issues certificates for those that meet the State or foreign TABLE FDA 3038 Dated: June 3, 2003. Jeffrey Shuren. Assistant CommIssionerfor Policy. (FR Dot. 03-14622 Filed 6-10-03; 8:45 am1 CODE 41-l-5 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration No. 02N-03831 Agency Information Collection Activities; Announcement of OMB Approval; Veterinary Adverse Drug Reaction, Lack of Effectiveness, Product Defect Report Food and Drug Administration. AGENCY: HI-IS. ACTION: Notice. The Food and Drug . Administration (FDA) is announcing that a collection of information entitled “Veterinary Adverse Drug Reaction. Lack of Effectiveness, Product Defect Report” has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. SUMMARY: FOR FURTHER INFORMATION CONTACT: Denver Presley, Office of Information Resources Management (HFA-250). Food and Drug Administration, 5600 Fishers Lane, Rockville. MD 20857, 301-827-1472. SUPPLEMENTARY processed by uncertified processors in other States and foreign nations. Consequently. the NSSP would not be able to control the distribution of uncertified, and possibly unsafe. shellfish in interstate commerce. and its effectiveness would be nullified. In the Federal Register of March 6, 2003 (68 F’R 10730) FDA published a 60-day notice.requesting public comment on the information collection provisions. No comments were received. FDA estimates the burden of this collection of information as follows: ANNUAL REPORTING BURDEN’ Annual Frequency per Response 62 Hours per Response Total Annual Responses 2.108 / 101 Total Hours 211 and maintenance costs associated with this collection of information. This estimate is based on the numbers of certificates received in the past 3 years. [Docket 1 .-ESTIMATED 34 1 There are no capital costs or operating June 11, 2003!Notices shellfish control authority’s criteria. Each participating State and nation provides a certificate of its certified shellfish processors to FDA on Form FDA 3038 entitled “Interstate Shellfish Dealer’s Certificate.” FDA uses this information to publish the “Interstate Certified Shellfish Shippers List,” a monthly comprehensive listing of all molluscan shellfish processors certified under the cooperative program. If FDA did not collect the information necessary to compile this list, participating States would not be able to identify and keep out shellfish No. of Respondents FDA Form No. BILLING 68, No. 1121 Wednesday, INFORMATION: In the Federal Register of March 7,2003 (68 FR I 1117). the agency announced that the proposed information collection had been submitted to OMB for review and clearance under 44 USC. 3507. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910-0012. The approval expires on May 31,2004. FOR FURTHER INFORMATION CONTACT: Aileen H. Ciampa, Center for Drug Evaluation and Research (HFD-7). Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857.301-5942041. SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98417) (the 1984 amendments), which authorized the approval of duplicate Dated: June 4. 2003. versions of drug products approved Jeffrey Shuren, under an ANDA procedure. ANDA Assistant Commlssioner for Policy. sponsors must, with certain exceptions, [FR Dot. 03-14623 Filed 6-10-03: 8:45 am] show that the drug for which they are BtLLING CODE 4180-01-S seeking approval contains the same active ingredient in the same strength and dosage form as the “listed drug,” DEPARTMENT OF HEALTH AND which is a version of the drug that was HUMAN SERVICES previously approved under a new drug application (NDA). Sponsors of ANDAs Food and Drug Administration do not have to repeat the extensive clinical testing otherwise necessary to [Docket Nos. 02P-9391 and 02P~l4943 gain approval of an NDA. The only clinical data required in an ANDA are Determination That Brimonidine Tartrate Ophthalmic Solution 0.2% Was data to show that the drug that is the subject of the ANDA is bioequivalent to Not Withdrawn From Sale for Reasons the listed drug. of Safety or Effectiveness The 1984 amendments include what AGENCY: Food and Drug Administration, is now section 606(j)(7) of the Federal HHS. Food, Drug, and Cosmetic Act (21 USC. 365(j)(7)), which requires FDA to ACTION: Notice. publish a list of all approved drugs. SUMMARY: The Food and Drug FDA publishes this list as part of the Administration (FDA) has determined “Approved Drug Products with that Alphagan 0.2% (hrimonidine Therapeutic Equivalence Evaluations.” tartrate ophthalmic solution) was not which is generally known as the withdrawn from sale for reasons of “Orange Book.” Under FDA regulations, safety or effectiveness. This drugs are withdrawn from the list if the determination will allow FDA to agency withdraws or suspends approval approve of the drug’s NDA or ANDA for reasons . .abbreviated new drug apphcatlons (ANDAs) for brimonidine of safety or effectiveness or if FDA tartrate ophthalmic solution 0.2%. determines that the listed drug was Federal Register / Vol. 68, No. 112 / Wednesday, June 11, 2003 / Notices 34981 wo-vear service commitment is r equired. There is no guarantee that Irarticipants in this demonstration Elroject will have an opportunity to c:ontinue their service and loan epayments beyond the initial two-year service period. Chiropractors and lharmacists. with qualifying educational loans, must serve at organized primary health care sites in Primarv Care HPSAs that have another d”l.A phagan 0.2% (brimonidine tartrate NHSC clinician on staff who will be ophthalmic solution) is the subject of concurrently fulfilling an NHSC service NDA 20-613, held by Allergan, Inc. commitment through the scholarship or (Allergan). Alphagan 0.2% is loan repayment program and who is administered as an eye drop to lower licensed to prescribe medications. This demonstration project will intraocular pressure in patients with include an evaluation component to open-angle glaucoma or ocular determine whether adding chiropractors hypertension. FDA approved NDA 20and pharmacists as permanent NHSC 613 on September 6, 1996. In a letter members would enhance the dated August 20. 2002, Allergan effectiveness of the NHSC. A maximum informed FDA that it was withdrawing of 36 individuals will be awarded loan Alphagan 0.2% from the market. In a reoavment contracts under this letter dated September 6. 2002, Allergan demonstration project. clarified that ii was not requesting that Purpose: Eligible chiropractors and auuroval be withdrawn for NDA 20pharmacists will participate in the Loan 6?;, nor was Alphagan 0.2% being Repayment Demonstration Project to recalled from the market. Instead, determine whether their services will Allergan explained that it was in the enhance the effectiveness of the NHSC. process of discontinuing distribution of Legislative Authority: These Alphagan 0.2%. Following receipt of applications are solicited under section Alierg&‘s letters, the agency moved 336L of the Public Health Service (PHS) Alohaean 0.2% from the “Prescription Act, as amended by Pub. L. 107-251. D&g Product List” section to the Eligible Applicants: Eligible “Discontinued Drug Product List” applicants must (1) be citizens or section of the Orange Book. nationals of the United States. (2) In citizen petitions submitted under possess a current unrestricted license to 21 CFR 10.30 and dated August 27,2002 practice as a chiropractor or pharmacist (Docket No. OZP-O404/cPl), and August in the State in which they intend to 30. 2002 (Docket No. 02P-O391/CPl), practice, (3) be negotiating or have respectively, Alcon. Inc. (Alcon), and secured employment at an eligible IVAN Pharmaceuticals, Inc. (IVAX), community site, and (4) meet the Assistant Commlssronerfor Policy. requested that the agency determine additional eligibility requirements whether brimonidine tartrate [FRDoc. 03-14660 Filed 6-10-03;6:45 am] outlined in the application materials. ophthalmic solution 0.2% was BILLING CODE 4166-61-S Chiropractors must also have a doctor of withdrawn from sale for reasons of chiropractic degree from a four-year safety or effectiveness. On October 26, chiropractic college that is currently DEPARTMENT OF HEALTH AND 2002. Allergan submitted a citizen fully accredited by the Commission on HUMAN SERVICES petition [Docket No. 02P-O469/CPl) Accreditation of the Council on opposing the granting of Alcon’s and Health Resources and Services Chiropractic Education, and WAY’s uetitions. Comments were Administration successfully passed the entire submitted in response to Allergan’s examination by the National Board of petition on November 13, 2002, and and Pharmacist Loan Chiropractic Examiners. Pharmacists December 6.2002, by Alcon and Bausch Chiropractor Repayment Demonstration Project must also have a baccalaureate or doctor & Lomb. Inc. (Bausch s( Lomb). of pharmacy degree from a school that respectively. Allergan responded to the AGENCY: Health Resources and Services is currentlv fullv accredited by the comments on January 23.2003. Bausch Administration (HRSA), HHS. American Council on Pharmaceutical & Lomb submitted additional comments ACTION: General notice. Education. on February 10, 2003, and Allergan Funding Priorities or Preferences: SUMMARY: The Health Resources and res onded on March 18.2003. Priority will be given to (A) applicants Services Administration (HRSA) &I A has considered the information who have characteristics that increase announces that applications from contained in the citizen petitions. the probability of their continuing to qualified chiropractors and pharmacists comments, and agency records and has practice in HPSAs after they have determined that Alphagan 0.2% was not who agree to serve underserved populations in Primary Care Health completed service, and (B) subject to withdrawn from sale for reasons of paragraph (A), applicants from safety or effectiveness. There are several Professional Shortage Areas (HPSAs) throughout the Nation will be accepted disadvantaged backgrounds. A funding grounds for FDA’s tinding. First, preference will also be given to by the National Health Service Corps Alphagan 0.2% has a safety and applicants serving Primary Care HPSAs (NHSC) for loan repayment awards. A effectiveness profile that is comparable withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162). Under S 314.161(a)(l) (21 CFR 314.161(a)(l)). the agency must determine whether a listed drug was withdrawn from sale for reasons of safety or effectiveness before an ANDA that refers to that listed drug may be approved. FDA may not approve an ANDA that does not refer to a listed .o that of Alphagan P (brimonidine artrate ophthalmic solution 0.X%), the subject of NDA 21-262 approved March 16.2001. for the same indication as Alphagan 0.2%. Approval of Alphagan P was based. in part, on references to the safety and efficacy of Alphagan 0.2% and the products’ comparability as demonstrated in head-to-head studies. Second. FDA has independently evaluated relevant literature and data for possible postmarketing adverse event reports regarding brimonidine tartrate ophthalmic solutions, but has found no information that would indicate that Alphagan 0.2% was withdrawn for reasons of safety or effectiveness. After considering the information contained in the citizen petitions, comments, and agency records, FDA determines that, for the reasons outlined above, brimonidine tartrate ophthalmic solution 0.2% approved under NDA 20613 was not withdrawn from sale for reasons of safety or effectiveness. Accordingly, the agency will continue to list Alphagan 0.2% (brimonidine tartrate ophthalmic solution) in the “Discontinued Drug Product List” section of the Orange Book. The “Discontinued Drug Product List” delineates, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. ANDAs that refer to Alphagan 0.2% (brimonidine tartrate ophthalmic solution) may be approved by the agency. Dated: June 4. 2003. Jeffrey Shuren. I i