Search Results for keywords:"Orange Book"

The Food and Drug Administration (FDA) announced that certain drug products, including ARALEN (Chloroquine Phosphate) oral tablets, were not removed from the market due to safety or effectiveness issues. This means that the FDA will continue to allow the approval of generic versions of these drugs through abbreviated new drug applications (ANDAs). The drugs will remain listed in the FDA's "Discontinued Drug Product List" in the Orange Book, indicating that their discontinuation was for reasons other than safety or effectiveness. If necessary, the FDA may request updates to the labels of these drugs to meet current standards.

The Food and Drug Administration (FDA) confirmed that RIOMET, a metformin hydrochloride oral solution, was not taken off the market for safety or effectiveness issues. This finding means that the FDA can continue approving generic versions of this medication if they meet legal requirements. RIOMET is listed as discontinued in the FDA's "Orange Book," but this is not due to any safety concerns. As a result, companies can still seek approval to produce generic versions of RIOMET, provided they comply with all necessary regulations.

The Food and Drug Administration (FDA) announced that certain drug products, including Bentyl Preservative Free (Dicyclomine Hydrochloride) Injection, 10 Milligrams/Milliliters, have not been taken off the market for safety or effectiveness issues. This means that generic versions of these drugs can still be approved by the FDA and sold, as long as they follow the necessary legal and regulatory guidelines. The drugs will be listed in the "Discontinued Drug Product List" in the Orange Book because they are no longer being sold, but not for reasons related to safety or effectiveness.

The Food and Drug Administration (FDA) has determined that DECADRON, a medication with the active ingredient dexamethasone sodium phosphate, was not taken off the market for reasons related to safety or effectiveness. This decision allows continued approval of generic versions of the drug as long as they comply with necessary legal and regulatory standards. DECADRON will remain on the "Discontinued Drug Product List," which includes drugs discontinued for reasons other than safety or effectiveness. The FDA reviewed data and found no evidence of safety concerns leading to the drug's withdrawal.

The Food and Drug Administration (FDA) has determined that the drug FLUMADINE (rimantadine hydrochloride) 100 mg tablets were not taken off the market due to safety or effectiveness concerns. As a result, the FDA will not start withdrawing approval for generic versions of this drug, and it may continue approving them if they meet legal standards. FLUMADINE was originally approved in 1993 for treating and preventing influenza A in adults and for prevention in children. Despite being discontinued by the manufacturer, it remains listed in the Orange Book as discontinued for reasons other than safety or effectiveness.

The Food and Drug Administration (FDA) has determined that NASCOBAL, a nasal spray containing 0.5 mg of cyanocobalamin (vitamin B12), was not removed from the market due to safety or effectiveness concerns. This decision means that the FDA will continue to approve generic versions of NASCOBAL as long as they meet all legal and regulatory requirements. The drug remains listed in the "Discontinued Drug Product List" section of the Orange Book, which indicates it was not discontinued for safety reasons. If needed, the FDA will instruct generic drug makers to update their labeling to current standards.