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For more information on the NDA process, please see " The FDA's Drug Review Process: Ensuring Drugs Are Safe and Effective." OTC drugs are: Drugs that do NOT require a doctor's prescription. Call your doctor if your insomnia worsens or is not better within 7 to 10 days. This may mean that there is another condition causing your sleep problems. LUNESTA may cause serious side effects that you may not know are happening to you including daytime.
All decisions regarding patient care must be made with a healthcare professional, considering the unique characteristics of the patient. Remember that no medicine is for everyone. Only your healthcare professional can prescribe LUNESTA for you.
Call your doctor if you experience these or any effects or reactions that concern you. LUNESTA, like most sleep medicines, carries some risk of dependency. Side effects may include unpleasant taste, headache, morning drowsiness and dizziness.
IMPORTANT SAFETY INFORMATION Do not take more LUNESTA than prescribed. LUNESTA acts quickly, so take it right before bed, and only if you have 7-8 hours to devote to sleep. Do not take LUNESTA if you are allergic to anything in it.
When the pain reliever acetaminophen was developed in the 1950s, it was only available under its brand name, Tylenol. Today, acetaminophen can be found in many generic and store-brand versions. Similarly, many drug products, prescription and over-the-counter, have generic versions available.
Sunovion Pharmaceuticals Inc. is a U.S. subsidiary of Sumitomo Dainippon Pharma Co. Ltd., and is a registered trademark of Sumitomo Dainippon Pharma Co. Ltd. 2015 Sunovion Pharmaceuticals Inc. All rights reserved.
Bought off-the-shelf in stores Regulated by FDA through OTC Drug monographs. OTC drug monographs are a kind of "recipe book" covering acceptable ingredients, doses, formulations, and labeling. Monographs will continually be updated adding additional ingredients and labeling as needed.
This may mean that there is another condition causing your sleep problems. LUNESTA may cause serious side effects that you may not know are happening to you including daytime sleepiness, not thinking clearly, acting strangely, confused or upset, or walking, eating, driving or engaging in.
The law also encourages generic firms to challenge innovator patents by awarding marketing exclusivity to the first generic version challenger. Generic drugs are safe, effective and FDA-approved. According to Gary Buehler, M.D., director of the FDA's Office of Generic Drugs, "People can use them with.
Article The law that allows approval of generic products, the Drug Price Competition and Patent Term Restoration Act of 1984, builds in certain protections for the original drug developer (including patents and marketing exclusivities but also allows drug sponsors of identical products to apply for.