Presentation is loading. Please wait.

Presentation is loading. Please wait.

NDAC/PADAC Joint Meeting May 11, 2001 Cazemiro R. Martin Regulatory Review Chemist FDA, Division of OTC Drug Products.

Similar presentations


Presentation on theme: "NDAC/PADAC Joint Meeting May 11, 2001 Cazemiro R. Martin Regulatory Review Chemist FDA, Division of OTC Drug Products."— Presentation transcript:

1 NDAC/PADAC Joint Meeting May 11, 2001 Cazemiro R. Martin Regulatory Review Chemist FDA, Division of OTC Drug Products

2 Prescription Availability Durham-Humphrey Amendment to the Federal FD&C Act (1951)

3 Durham-Humphrey Amendment n 503(b)(1)(A) : Because of toxicity or potentially harmful effects (not safe unless used under supervision) or…. or…. n 503(b)(1)(B) : Limited by approved application to use under supervision

4 OTC Availability n New Drug Application Process (NDA) – Prescription (Rx)-to-OTC Switch process – Marketed directly OTC n OTC Drug Monograph Process – Established conditions under which OTC drug products are generally recognized as safe and products are generally recognized as safe and effective (GRAS/E) effective (GRAS/E)

5 NDA Process Rx-to-OTC Considerations: n Can the condition be adequately self-recognized? self-recognized? n Can the condition be successfully self-treated? self-treated? n Is the self-treatment product safe and effective during consumer use? and effective during consumer use?

6 NDA Process Rx-to-OTC Switch Candidate: n Acceptable margin of safety based on prior prescription marketing experience prescription marketing experience n OTC dosages/indications are relatively safe - low misuse potential - low misuse potential - minimal abuse potential - minimal abuse potential - reasonable therapeutic window of safety - reasonable therapeutic window of safety

7 NDA Process Rx-to-OTC Switch Candidate (cont.) n Self-treatment and self-monitoring with minimal physician supervision with minimal physician supervision n Adequately labeled to allow safe and effective use of the OTC drug and effective use of the OTC drug n Benefits from the OTC switch clearly outweigh the risks outweigh the risks

8 OTC Drug Monograph Process n Advisory Review Panel n Advance Notice of Proposed Rulemaking - advisory panel report Rulemaking - advisory panel report n Tentative Final Monograph n Final Monograph

9 Advisory Review Panel OTC Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products

10 Advanced Notice of Proposed Rulemaking Panel’s Antihistamine Review Panel’s Antihistamine Review n Effective in suppressing symptoms of allergic rhinitis (such as hay fever) rhinitis (such as hay fever) n Low order of acute and chronic toxicity

11 Advisory Panel Report (Antihistamine Review - cont.) n Common side effects - rarely serious » CNS depression: drowsiness » Anticholinergic: dryness of the mouth; urinary retention; reduced bronchial urinary retention; reduced bronchial secretions secretions n Rarely occurring side effects » Cardiovascular, gastrointestinal, hematological

12 Advisory Panel Report (Antihistamine Review - cont.) n Labeling recommendations: Uses: temporary relief of symptoms associated with allergic rhinitis with allergic rhinitis Warnings: » may cause drowsiness » avoid driving or operating machinery » avoid alcoholic drinks » consult a physician before use if you have difficulty in urination or difficulty breathing difficulty in urination or difficulty breathing

13 Tentative Final Monograph January 15, 1985

14 Final Monograph (OTC Antihistamines) 21 CFR 341 n 13 antihistamine active ingredients marketed under the OTC drug monograph system under the OTC drug monograph system n Final rule addresses “allergy” indications only n Labeling of OTC antihistamine drug products

15 OTC Monograph Antihistamines 21 CFR n Brompheniramine maleate n Chlorcyclizine HCl n Chlorpheniramine maleate n Dexbrompheniramine maleate n Dexchlorpheniramine maleate n Diphenhydramine citrate n Diphenhydramine HCl n Doxylamine succinate n Phenindamine tartrate n Pheniramine maleate n Pyrilamine maleate n Thonzylamine HCl n Triprolidine HCl

16 OTC NDA/ANDA Antihistamines Extended Release: Extended Release:  Brompheniramine maleate  Chlorpheniramine maleate  Dexbrompheniramine maleate  Triprolidine HCl Immediate Release:  Clemastine fumarate

17 Nonmonograph Ingredients n Methapyrilene fumarate n Methapyrilene HCl n Phenyltoloxamine dihydrogen citrate dihydrogen citrate n Promethazine HCl n Thenyldiamine HCl n Tripelennamine HCl - potential carcinogen - inadequate efficacy data - tardive dyskinesia: causal role - single ingredient: no long-term use - inadequate efficacy data - safe/effective:no data submitted

18 OTC Antihistamines Drug Facts Labeling Drug Facts Labeling 21 CFR Format and Content Requirements for OTC Drug Product Labeling

19

20 Summary n OTC Drug Products: – acceptable margin of safety (minimal toxicity) – low potential for harmful effects – low misuse/minimal abuse potential – reasonable therapeutic window of safety n Self-treatment and self-monitoring n Adequately labeled to allow safe and effective use n Benefits outweigh risks


Download ppt "NDAC/PADAC Joint Meeting May 11, 2001 Cazemiro R. Martin Regulatory Review Chemist FDA, Division of OTC Drug Products."

Similar presentations


Ads by Google