scholarly journals Manufactures Human Over-the-Counter Drug Products Produced Under an Approved Drug Application

2020 ◽  
Author(s):  
Keyword(s):  
Drug Application ◽  
Over The Counter ◽  
Drug Products

Abbreviated New Drug Application Process: A Gift for The Industry and The Patients

2021 ◽  
pp. 331-335
Author(s):  
Hindustan Abdul Ahad ◽  
Haranath Chinthaginjala ◽  
Gangireddy Jayasimha Reddy ◽  
Pasupuleti Dheeraj Krishna ◽  
Syed Rahamathulla ◽  
...  
Keyword(s):  
Drug Application ◽  
The United States ◽  
New Drugs ◽  
Brand Name ◽  
Application Process ◽  
Drug Products ◽  
Federal Food ◽  
United States Food ◽  
States Food ◽  
New Drug Application

The United States Food and Drug Administration (USFDA) is one of the main regulated agencies wherein the submission and approval of the new drugs is done. This review is based on the process of submission to the ANDA as per FDA norms as described in paragraph IV submission in Federal Food, Drug, and Cosmetic Act (FD and C Act). No drug would exist in the market until it gets accepted by regulatory authorities. The ANDA submission is for those firms seeking to copy branded drugs before running out of patents to get profit on them. A generic applicant must provide in its application a "certification" that a patent submitted to FDA by the brand-name drug's sponsor and scheduled in FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (the Orange Book). A Generic Product must meet the standards recognized by FDA in Reference listed drugs (RLD). This study concludes the process of ANDA submission to FDA and acts correlated to the submission in paragraph IV, the details of ANDA filling in the eCTD format and overview of the review process the checklist to the applicant.

Podophyllum–A Dangerous Laxative

PEDIATRICS ◽  
1976 ◽  
Vol 57 (3) ◽  
pp. 419-421
Author(s):  
Gladys Rosenstein ◽  
Herman Rosenstein ◽  
Martha Freeman ◽  
Nathan Weston
Keyword(s):  
Drug Administration ◽  
Food And Drug Administration ◽  
Antiemetic Drug ◽  
Review Panel ◽  
Over The Counter ◽  
Drug Products ◽  
Bilateral Absence ◽  
Independent Evaluation ◽  
Available Information ◽  
Intensive Search

A physician asked the Food and Drug Administration (FDA) for information regarding podophyllum. He had under his care an infant born with phocomelia manifested by bilateral absence of the radii. During her pregnancy, the child's mother had occasionally taken a laxative which contained podophyllum as one of its active ingredients. This inquiry led to an intensive search for available information on this subject. The discussion below is a summary of this information. From the data it was determined that podophyllum is too toxic a drug to be used as a laxative, especially since much safer laxatives are available. The FDA Advisory Review Panel on Over-the-Counter (OTC) Laxative, Antidiarrheal, Emetic and Antiemetic Drug Products, in a recently completed independent evaluation, similarly concluded that podophyllum resin is an unsafe laxative.

Comprehension Testing for OTC Drug Labels: Goals, Methods, Target Population, and Testing Environment

1998 ◽  
Vol 17 (1) ◽  
pp. 86-96 ◽  
Author(s):  
Louis A. Morris ◽  
Karen Lechter ◽  
Michael Weintraub ◽  
Debra Bowen
Keyword(s):  
Drug Administration ◽  
Food And Drug Administration ◽  
Target Population ◽  
Low Literacy ◽  
Over The Counter ◽  
Testing Environment ◽  
Complex Products ◽  
Drug Products ◽  
Label Information

Drug products may be switched from precription (Rx) to over-the-counter (OTC) status if labeling can be written that ensures that the label information is comprehensible to ordinary consumers, including persons with low literacy ability, under normal conditions of purchase and use. The Food and Drug Administration has been working with sponsors to develop methods to test consumer comprehension of proposed OTC product labels. The authors discuss several conceptual and operational elements of comprehension testing, focusing on the goals, methods, appropriate target audience, and testing environment. The authors also examine areas in need of further research and debate. As more complex products are considered for OTC status, it is even more important to ensure that OTC labels are comprehensible. As understanding and the validity of methods to evaluate consumer comprehension improve, so should the quality of labels offered to consumers.

Final Report On the Safety Assessment of Benzoxiquine1

1997 ◽  
Vol 16 (1_suppl) ◽  
pp. 117-122
Author(s):  
F. Alan Andersen
Keyword(s):  
Safety Assessment ◽  
Safety Data ◽  
Metabolic Activation ◽  
Final Report ◽  
Cosmetic Products ◽  
Over The Counter ◽  
Drug Products ◽  
Ocular Irritation ◽  
Dermal Irritation ◽  
Mammalian System

Benzoxiquine is described as a biocide for use in cosmetic products. It is currently reported to be used in only one product. In a separate finding, the Food and Drug Administration determined that Benzoxiquine is not generally recognized as safe and effective in over-the-counter topical antifungal drug products. The only data available on the toxicity of Benzoxiquine indicates that it is mutagenic in the Ames test without metabolic activation. Because of the lack of data, the safety of Benzoxiquine could not be substantiated. The data needed to make a safety assessment include purity/impurities, ultraviolet absorption (if there is absorption, then photosensitization data will be needed), 28-day dermal toxicity, dermal teratogenicity, ocular irritation (if already available only), dermal irritation and sensitization, and two different genotoxicity studies (one using a mammalian system). If the latter data are positive, dermal carcinogenesis data using the methods of the National Toxicology Program will be needed. It cannot be concluded that Benzoxiquine is safe for use in cosmetic products until these safety data have been obtained and evaluated.

scholarly journals Knowledge, attitude, beliefs and use of over the counter drug products among medical undergraduates

2017 ◽  
Vol 6 (6) ◽  
pp. 1358
Author(s):  
Mamta Rani ◽  
M. C. Gupta
Keyword(s):  
Medical Students ◽  
Prescription Drugs ◽  
General Information ◽  
Drug Label ◽  
Medical Problems ◽  
Over The Counter ◽  
Drug Products ◽  
Validated Questionnaire ◽  
Medical Undergraduates ◽  
Day By Day

Background: Over the counter (OTC) drug products are available without prescription and considered safe, effective, affordable and easily accessible. Among medical students use of OTCs and even prescription drugs available as OTCs is increasing day by day. The objective of the study was carried out to assess the knowledge, attitude and beliefs about OTCs, their use, safety and regulatory issues of OTCs among medical undergraduates.Methods: A questionnaire-based study was conducted and 151 medical students participated in this study. A preformed and validated questionnaire consisting of 2 parts was used. Part 1 consisted of general information regarding OTCs and Part 2 consisted information about knowledge, attitude, beliefs and use of OTCs. Data were analyzed and the results were expressed as percentages.Results: 100% participating students were aware about OTCs. 70% used them a lot because of availability and belief on safety. Chemist was a good source of advice over minor medical problems according to 38% of students. Information to be read on drug label was known to 62.5% of them. Affordability and accessibility (84%) was the main reason for OTCs use. Common medications bought without prescription were antibiotics, antihistaminics (100%) and cough syrups (90%). Headache and fever (100%), acidity (91%) were common indications for OTC use. Common OTCs stored at home were painkiller, antacids and skin care products.Conclusions: All students though were aware of OTCs but had little knowledge of regulation and usage. Many prescription drugs were also available as OTCs. Medical students need to be educated and trained about OTCs and the related issues. 

Information Technology & FDA Compliance in the Pharmaceutical Industry

2011 ◽  
pp. 262-273
Author(s):  
Raymond Papp
Keyword(s):  
Information Technology ◽  
Pharmaceutical Industry ◽  
Food And Drug Administration ◽  
Drug Application ◽  
Over The Counter ◽  
Electronic Submission ◽  
Current Process ◽  
New Drug ◽  
Corporate Goals ◽  
New Drug Application

Given the recent profitability of and demand for pharmaceuticals, from prescription antibiotics and analgesics like Ciproflaxin and OxyContin and mens health drugs such as Viagra and Vardenafil to over-the-counter Senokot laxatives and Betadine antiseptics, the rush to develop and market new pharmaceuticals has never been greater. The current process is complex and it often takes several years for a drug to reach the market due to the myriad of Food and Drug Administration (FDA) guidelines. Furthermore, the recent FDA guidelines mandating that all New Drug Applications (NDA) be submitted in electronic (paperless) format by the end of 2002 is a catalyst for change in the pharmaceutical industry (FDA Proposes First Requirement for Electronic Submission, 2002; New Drug Application (NDA), 2001). Bayer Pharmaceutical, like its competitors Purdue Pharma and Boots Healthcare, has begun to take steps to assure that its use of information technology will allow it to not only meet FDA guidelines, but achieve its corporate goals of improved efficiency and reduced operating costs.

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