Pepcid ac sample
Another variable in this equation was the dual claim indication that JJM is planning to file. Considering that JJM already has a presence in the antacid OTC market with Mylanta, having Pepcid AC in a higher price range would be a way to clearly distance the 2 drugs from each other and reduce the risk of cannibalization.
Traditionally, the FDA prefers education over medication for purposes of prevention. The reason cited is the risk of overmedication that OTC drugs could pose if used for prevention of a disease. Three courses of action are possible for JJM at this point: Pepcid AC safer than Tagamet side effects when used with other drugs Strong brand name.
Convenient 1 tablet dosage Last longer than traditional antacids Indicated for both treatment and prevention of heartburning versus treatment only claim of Tagamet. Priced higher than traditional antacids Takes longer than traditional antacids to start acting Higher cost than Tagamet due to license fees Opportunities: Comparing the Strengths and Weaknesses of both, Pepcid is safer to use with less restrictions when combined with other drugs, and is planning to claim both treatment and prevention of heartburn, versus only the treatment claim of Tagamet.
Tagamet also has the advantage of having started earlier in the OTC transition process. The greatest opportunity for Pepcid against Tagamet, is the potential for gaining market share in the heartburn treatment market. Another aspect to be highlighted, is the pricing strategy. If priced too low, Pepcid AC could present a significant cannibalization risk to Pepcid. Pepcid AC x Traditional antacids: Similar to its competitors in the H2 receptor antagonists market, JJM has strong participation in the traditional antacid smarket.
The main strength of Pepcid AC versus Mylanta and other traditional antacids is the indication for both prevention and treatment depending on the option chosen. The opportunity for Pepcid AC is gaining market share from the other companies in the regular antacid market. As a consequence, there is considerable risk of rejection if JJM a proceeds with filing for regulatory approval for prevention and treatment claims with only the available clinical data. Although not a necessary rule, the FDA typically follows the advice rendered by their advisory committee.
An alternative course of action is b to conduct additional clinical trials, in order to conclusively prove efficacy of Pepcid AC, for both treatment and prevention of heartburn.
In the case of H2 antagonists, being first-to-market is perceived as an important competitive advantage, enabling the first entrant to capture and retain the bulk of market share. Furthermore, being first-to-market could facilitate establishment of long-term customer loyalty relationships.. However, this approach could be viewed as overly conservative since JJM has already conducted extensive clinical trials to prove efficacy of Pepcid AC for both treatment and prevention claims.
JJM strongly believed that these trials already provided sufficient evidence in support of the prevention claim and that additional trials were unnecessary. Therefore, conducting additional trials is a course of action to be pursued only as a contingency plan; that is,iif regulatory approval is not achieved with the currently available clinical data. Alternatively, JJM could move forward with c filing for regulatory approval for the treatment claim only.
This approach is believed to be the easier path to achieving approval, when compared to pushing for approval of both treatment and prevention claims. Typically, the FDA views education as preferable over medication for prevention. Therefore, the agency may have inherent resistance to approving prevention claims. As such, the potential for regulatory dismissal of prevention claims is a valid concern.
Seeking approval for the treatment claim only may appear to be the easier path to regulatory approval, but this is not an option without downside risk. In pursuing this alternative course of action, JJM would be sacrificing their key point of difference and diminishing the value proposition of the product. Furthermore, the lack of the prevention label could result in a significant reduction of market share and loss of revenue. Although results from BASESII market research support that treatment only claim is the most important one for product positioning, concept tests and focus groups support the notion that prevention and treatment together are more important.
Additionally, heavy heartburn drug users, which account for the greatest potential usage and customer loyalty of Pepcid AC, strongly favor the treatment and prevention claims. Therefore, pursuing treatment only approval may not necessarily be the best path forwards.
JJM has already conducted sufficient clinical studies supporting both indications. Famotidine belongs to a class of drugs known as H2 blockers.
This medication is also available without a prescription. It is used to prevent and treat heartburn and other symptoms caused by too much acid in the stomach acid indigestion. If you are taking this medication for self-treatment, it is important to read the manufacturer's package instructions carefully so you know when to consult your doctor or pharmacist. How to use Pepcid AC Take this medication by mouth with or without food as directed by your doctor, usually once or twice daily.
If you are taking this medication once daily, it is usually taken at bedtime. The dosage and length of treatment are based on your medical condition and response to therapy.
In children, dosage may also be based on body weight. You may take other medications e. Follow your doctor's instructions carefully. Consult your doctor or pharmacist if you have any questions. Take this medication regularly in order to get the most benefit from it.
Pepcid AC Case Study
The reason cited is the risk of overmedication that OTC samples could pose if used for prevention of a disease. Follow your doctor's instructions carefully. Although not a necessary rule, the FDA typically follows the pepcid rendered by their advisory committee. As such, the potential for regulatory dismissal of prevention claims is a valid concern. Furthermore, heavy users are likely to be early adopters of the new offering and tend to be opinion leaders, pepcid ac sample, which will set the tone for the customer perceived value of the product Behavioral market research also revealed that patients that used prescription H2 receptors antagonists learned that with regular use of the medication they could prevent the onset of heartburn. JJM has already conducted sufficient clinical studies supporting both indications. If priced too low, Pepcid AC could present a sample cannibalization risk to Pepcid. Although results from BASESII market research support that treatment only claim is the most important one for product positioning, concept tests and pepcid groups support the notion that prevention and treatment together are more important. Furthermore, being first-to-market could facilitate establishment of long-term customer loyalty relationships. The opportunity for Pepcid AC is gaining market share from the other companies in the regular antacid market. It works by decreasing the amount of acid your stomach makes, pepcid ac sample.
Famotidine Side Effects
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