THE WEINBERG GROUP VIA FEDEX. October l, 2009

Transcription

1 .. 0 THE WEINBERG GROUP VIA FEDEX October l, 2009 Division of Dockets Management Food and Drug Administration (HFA-305) Department of Health and Human Services 5630 Fishers Lane, Room 1061 Rockville, MD Dear Sir or Madam: SUITABILITY PETITION This petition is submitted pursuant to 21 CFR and 10.30, as provided for in 21 CFR and Section 505(j)(2)(c) of the Federal Food, Drug, and Cosmetic Act, to request the Commissioner of the Food and Drug Administration to declare that the drug product chlorpheniramine maleate 8 mg and pseudoephedrine hydrochloride 120 mg extended-release (ER) capsules, are suitable for submission as an Abbreviated New Drug Application (ANDA). A. Action Required The petitioner requests that the Commissioner of the Food and Drug Administration declare that chlorpheniramine maleate 8 mg and pseudoephedrine hydrochloride 120 mg ER capsules are suitable for the submission as an ANDA. The reference listed drug product upon which this petition is based is Chlor-Trimeton Allergy/Decongestant (chlorpheniramine maleate 8 mg and pseudoephedrine sulfate 120 mg extended release tablets), under NDA 18,397 (see copy of page from the current electronic edition of the Approved Drug Products with Therapeutic Equivalence Evaluations, Attachment 1). This petition requests a change in dosage form from the reference drug product (tablet to capsule) and a change in active ingredient (pseudoephedrine sulfate to pseudoephedrine hydrochloride). The dosage strength, the route of administration, and the recommendations for use are the same as those of the listed drug product. The proposed product would differ in dosage form and active ingredient from the marketed Chlor-Trimeton Allergy/Decongestant product. The proposed drug product is expected to demonstrate bioequivalence to the aforementioned reference listed drug product. This data will be submitted at a later date. -- '-DA- 900 TheWeinberg Group Inc. J 1220 Nineteenth St, NW, Suite 300 I Washington, DC USA ~~ ~ /~j f ~,~~- 093,~.~ I F + 1? weinberggroup.com 1

2 Division of Dockets Management Food and Drug Administration October 1, 2009 Page 2 B. Statement of Grounds The Federal Food, Drug, and Cosmetic Act provides for the submission of an ANDA for a new drug that differs in dosage form from that of a listed drug provided the FDA has approved a petition that proposed the filing of such an application. In addition, CFRs (b) and (d) allow for a change in active ingredient to be substituted and for the identification of more than one listed drug when the proposed drug product is a combination product that differs from the combination reference listed drug in active ingredient. The changes are acceptable if the different active ingredient has previously been approved in a listed drug or is a drug that does not meet the definition of "new drug" in section 201(b) of the act. This petition requests a change in dosage form and active ingredient for the proposed drug from that of the reference listed drug. The proposed changes in dosage form and in active ingredient for the chlorpheniramine maleate 8 mg and pseudoephedrine hydrochloride 120 mg ER capsules from the reference Chlor-Trimeton Allergy/Decongestant extended release tablets does not present concern for safety or efficacy from that of the approved tablet strength. The chlorpheniramine maleate 8 mg and pseudoephedrine hydrochloride 120 mg ER capsules will have the same route of administration for the same intended population and the same recommendations for use as the Chlor-Trimeton Allergy/Decongestant product. Therefore, there will be no difference in the safety and efficacy of the proposed chlorpheniramine maleate 8 mg and pseudoephedrine hydrochloride 120 mg ER capsules. According to the approved labeling for the reference listed drug product, Chlor-Trimeton Allergy/Decongestant (chlorpheniramine maleate 8 mg and pseudoephedrine sulfate 120 mg ER tablets), is an antihistamine decongestant combination drug indicated for the treatment of sneezing, itchy and watery eyes, itchy throat, and runny nose caused by allergies such as hay fever and stuffy nose and sinuses. Having capsules available may benefit some patients who have difficulty swallowing tablets and prefer a capsule formulation. Thus, the proposed change in drug form from tablets to capsules will prove to be a clear benefit to the consumer and unlikely to present any efficacy or safety concerns. The pseudoephedrine component of the proposed product will differ from the reference product by replacing the pseudoephedrine sulfate with pseudoephedrine hydrochloride. Pseudoephedrine hydrochloride has previously been approved in several antihistamine decongestant combination over-the-counter drug products, as well as pseudoephedrine hydrochloride single ingredient products. These products include those that are single ingredient or are in combination with chlorpheniramine maleate and other antihistamines and analgesics. Examples include Sudafed 12-hour, Advil Allergy Sinus, and Zyrtec-D 12-hour. Given that these currently approved products contain the same dosage of pseudoephedrine hydrochloride as the proposed product, or contain pseudoephedrine hydrochloride in combination with chlorpheniramine, approval of the chlorpheniramine

3 Division of Dockets Management Food and Drug Administration October l, 2009 Page 3 maleate 8 mg and pseudoephedrine hydrochloride 120 mg ER capsules would not present additional safety concerns. The proposed product will differ from the listed drug in dosage form and active ingredient. The indications, route of administration, intended patient population, and recommendations for use will remain the same as for the Chlor-Trimeton Allergy/Decongestant product. Therefore there will be no difference in the safety and efficacy of the proposed capsules. The package insert for Chlor-Trimeton Allergy/Decongestant is provided in Attachment 2 of this petition. The draft package insert for the proposed chlorpheniramine maleate 8 mg and pseudoephedrine hydrochloride 120 mg ER capsules is provided in Attachment 3. C. Pediatric Use Information Under the Pediatric Research Equity Act of 2003, an application filed under section 505 for a new active ingredient, new indication, new dosage form, new dosing regimen, or new route of administration must submit with the application assessments of the use of the proposed product in pediatric populations, or request a waiver from providing those assessments. The proposed product, chlorpheniramine maleate 8 mg and pseudoephedrine hydrochloride 120 mg ER capsules, requests a change in dosage form and a change in active ingredient from the reference product, and is therefore subject to the Pediatric Research and Equity Act. The petitioner is requesting a full waiver of the pediatric assessment requirements to conduct pediatric studies, in accordance with the Pediatric Research Equity Act of 2003, and the waiver requirements set forth in the Act, Section 505B(a)(4)(A)(iii), as "the drug or biological product (1) does not represent a meaningful therapeutic benefit over existing therapies for pediatric patients ; and (11) is not likely to be used by a substantial number of pediatric patients." The petitioner would like to point out that multiple alternative antihistamine decongestant combination therapies are available for pediatric patients marketed as OTC monograph items with proper dosing as outlined in 21 CFR 341. The proposed formulation offers no advantage for pediatric patients over existing immediaterelease formulations of chlorpheniramine and pseudoephedrine and offers less dosing flexibility. Thus, Petitioner hereby requests a waiver of pediatric requirements. D. Environmental Impact An environmental assessment report on the action requested in this petition is not required under 21 CFR

4 Division of Dockets Management Food and Drug Administration October l, 2009 Page 4 E. Economic Impact The petitioner does not believe that this is applicable in this case, but will agree to provide such an analysis if requested by the agency. F. Certification The undersigned certifies that to the best of his knowledge, this petition includes all information and views on which the petition relies, and that it includes representative data and information known to the petitioner which are unfavorable to the petition. Very truly yours, Nicholas M. Fleischer, R.Ph., Ph.D. Vice President - Clinical Pharmacology & Biopharmaceutics The Weinberg Group Inc. NMF/kw Attachment 1. Attachment 2. Attachment 3. Approved Drug Products with Therapeutic Equivalence Evaluations available at : Cited 25 September 2009 Approved Labeling for Chlor-Trimeton Allergy/Decongestant Extended- Release Tablets Draft Labeling for Chlorpheniramine Maleate 8 mg and Pseudoephedrine Hydrochloride 120 mg Extended-Release Capsules

5 ATTACHMENT 1 APPROVED DRUG PRODUCTS WITH THERAPEUTIC EQUIVALENCE EVALUATIONS

6 Application Number Search Page 1 of 1 Application Number Search Results from "OB-OTC" table for query on " " Appl RLD Active Dosage Form ; Strength Proprietary Applicant No Ingredient Route Name Yes CHLORPHENIRAMINE TABLET, 8MG;120MG CHLOR- SCHERING MALEATE ; EXTENDED TRIMETON PLOUGH PSEUDOEPHEDRINE RELEASE ; SULFATE ORAL Return to Electronic Oranqe Book Home Paqe 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 July, 2009 Patent and Generic Drug Product Data Last Updated: September 04, 2009 http :// 9/8/2009

7 ATTACHMENT 2 APPROVED LABELING FOR CHLOR-TRIMETON ALLERGY/DECONGESTANT"' EXTENDED-RELEASE TABLETS

8 Brand name: chlor-trimeton Allergy/ Decongestant Pronounced: klor-tri-muh-ton Generic ingredients; Chlorpheniramine maleate, Pseudoephedrine sulfate What this drug is used for Like regular Chlor-Trimeton Allergy tablets, these tablets temporarily relieve the sneezing, itchy and watery eyes, itchy throat, and runny nose caused by allergies such as hay fever. In addition, they contain an ingredient to unclog stuffy nose and sinuses. The tablets come in 4-hour and 12-hour formulations. The 12-hour tablets are twice the strength of the 4-hour variety. How should you take this medication? * 4-HOUR ALLERGY/DECONGESTANT TABLETS Adults The usual dose for adults and children 12 and over is 1 tablet every 4 to 6 hours. Do not take more than 4 tablets in 24 hours. Children For children 6 to 12, break a tablet in half and give half a tablet every 4 to 6 hours. than 2 whole tablets in 24 hours. For children under 6, consult your doctor. Do not give more * 12-HOUR ALLERGY/DECONGESTANT TABLETS Adults The usual dose for adults and children 12 and over is 1 tablet every 12 hours. Do not take more than 2 tablets in 24 hours. Children Do not give to children under 12 unless your doctor approves. *STORAGE Store at room temperature. Protect from too much moisture.

9 Do not take this medication if... Unless your doctor approves, avoid Chlor-Trimeton Allergy/Decongestant if you have a breathing problem such as emphysema or chronic bronchitis, high pressure within the eye (glaucoma), heart disease, high blood pressure, thyroid disease, diabetes, or an enlarged prostate gland. Special warnings about this medication If you become nervous or dizzy, or if you have trouble sleeping while taking this product, stop using it and call your doctor. If you do not feel better in 7 days, or if you develop a fever, contact your doctor. Be aware that Chlor-Trimeton Allergy/Decongestant may cause over-excitement--especially in children. Because Chlor-Trimeton Allergy/Decongestant can make you drowsy, be especially careful when driving or operating machinery while taking this product. Possible food and drug interactions when taking this medication Do not use Chlor-Trimeton Allergy/Decongestant within 2 weeks of taking a drug classified as an MAO inhibitor, including the antidepressants Nardil and Parnate. If you are taking a tranquilizer such as Valium or Xanax, or a sleep aid such as Halcion or Seconal, do not take Chlor-Trimeton Allergy/Decongestant without your doctor's approval ; the combination could cause extreme drowsiness. For the same reason, avoid alcohol while taking this product.

10 ATTACHMENT 3 DRAFT LABELING FOR CHLORPHENIRAMINE MALEATE 8 MG AND PSEUDOEPHEDRINE HYDROCHLORIDE 120 MG EXTENDED-RELEASE (ER) CAPSULES

11 CHLORPHENIRAMINE MALEATE 8 MG AND PSEUDOEPHEDRINE HYDROCHLORIDE 120 MG EXTENDED- RELEASE (ER) CAPSULES Generic ingredients: Ch/orpheniramine maleate, Pseudoephedrine hydrochloride What this drug is used for Chlorpheniramine maleate 8 mg and pseudoephedrine hydrochloride 120 mg extended-release (ER) capsules temporarily relieve the sneezing, itchy and watery eyes, itchy throat, and runny nose caused by allergies such as hay fever. In addition, they contain an ingredient to unclog stuffy nose and sinuses. The capsules come in a 12-hour formulation. How should you take this medication? Adults The usual dose for adults and children 12 and over is 1 capsule every 12 hours. Do not take more than 2 capsules in 24 hours. Chi/dren Do not give to children under 12 unless your doctor approves. *STORAGE Store at room temperature. Protect from too much moisture. Do not take this medication if... Unless your doctor approves, avoid chlorpheniramine maleate 8 mg and pseudoephedrine hydrochloride 120 mg extended-release (ER) capsules if you have a breathing problem such as emphysema or chronic bronchitis, high pressure within the eye (glaucoma), heart disease, high blood pressure, thyroid disease, diabetes, or an enlarged prostate gland. Special warnings about this medication If you become nervous or dizzy, or if you have trouble sleeping while taking this product, stop using it and call your doctor. If you do not feel better in 7 days, or if you develop a fever, contact your doctor.

12 Be aware that chlorpheniramine maleate 8 mg and pseudoephedrine hydrochloride 120 mg extendedrelease (ER) capsules may cause over-excitement--especially in children. Because chlorpheniramine maleate 8 mg and pseudoephedrine hydrochloride 120 mg extended-release (ER) capsules can make you drowsy, be especially careful when driving or operating machinery while taking this product. Possible food and drug interactions when taking this medication Do not use chlorpheniramine maleate 8 mg and pseudoephedrine hydrochloride 120 mg extended-release (ER) capsules within 2 weeks of taking a drug classified as an MAO inhibitor, including the antidepressants Nardil and Parnate. If you are taking a tranquilizer such as Valium or Xanax, or a sleep aid such as Halcion or Seconal, do not take chlorpheniramine maleate 8 mg and pseudoephedrine hydrochloride 120 mg extendedrelease (ER) capsules without your doctor's approval ; the combination could cause extreme drowsiness. For the same reason, avoid alcohol while taking this product.

13 Page 1 of 1 From: Origin ID: JPNA (202) Kara Wilhelm The Weinberg Group 1220 Nineteenth Street NW Washington, DC fe7&1 E SHIP T0: (30t) BILL SENDER Div. of Dockets Management HFA-305 Food and Drug Administration 5630 FISHERS LN RM 1061 DEPT OF HEALTH & HUMAN SERVICES ROCKVILLE, MD r ~ y ~n~ ~r~~l' ~ 1~ ~ ' ~ II ~ ~ I~~I rj~l~ k i+l! ~~ ~ ~ ~ J' ~ ~ Ì + (~ f I L j. ~ V~, ~ ~f ` I IIti Ship Date : 010CT09 ActWgt 0.5 LB CAD: ANET9090 Account*. S" Delivery Address Bar Code II~IIIIIIIIIIIIIIIIIIIRIIIl~IAlllllllllll~l Ref # 170 PO # Dept # TRK# OBTA II~~ II~ FRI - 020CT A2 PRIORITY OVERNIGHT I I II I i i MD-US i IAD 11 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,consequential, 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. 10/1/2009