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The Fourth Circuit Upholds CMS’ Definition of “Line-Extension Drug” and “New Formulation”

The FDA Law Blog

Gaulkin — On April 10, the Fourth Circuit unanimously affirmed a summary judgment ruling for the Centers for Medicare & Medicaid Services (CMS) regarding the agency’s definitions of “line-extension drug” and “new formulation” for purposes of determining rebates that drug manufacturers may owe the Medicaid Drug Rebate Program (MDRP).

Dosage 59
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CMS Definition of “New Formulation” Upheld in Federal Court

The FDA Law Blog

Kirschenbaum — On March 31, the Federal District Court for the District of Maryland upheld CMS’s definition of a “new formulation” under the Medicaid Drug Rebate Program (MDRP). Examples in the regulation include extended-release formulations, new strengths, dosage forms, routes of administration, ingredients, and combinations.

Dosage 59
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Omeprazole for cats: Dosage and safety

The Checkup by Singlecare

More specific symptoms of feline esophagitis include: Regurgitation Swallowing problems Excessive swallowing Painful swallowing Excessive salivation As with stomach ulcers, veterinarians can only definitively diagnose esophagitis from an endoscopic examination. The dosages of these other drugs may need to be adjusted.

Dosage 52
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Levothyroxine for dogs: Dosage and safety

The Checkup by Singlecare

High thyroid hormone levels can’t be definitively established without a blood test. The recommended starting dosage in dogs is 0.02 They use clinical signs and blood tests to determine how well each dosage is working. The dosage strengths are too low. No maximum dosage has been established. mg/lb) daily.

Dosage 52
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Scrub-a-Dub-Dub: FTC is Cleansing the Orange Book of Device Patents

The FDA Law Blog

While the relevant regulation defines “drug product” as the “finished dosage form,” which theoretically includes the delivery device, the Court again falls back on the wording in 21 C.F.R. b)(1) that drug product patents may be listed if they claim the “drug product. that is described in the pending or approved NDA ” (emphasis added). .

Dosage 116
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Is famotidine safe during pregnancy?

The Checkup by Singlecare

There are no adequate or well-controlled studies in pregnant women to definitively say it’s risk-free. However, famotidine should be safe to use while breastfeeding as dosages of it have been administered to newborns in higher amounts than what is excreted in breast milk. Food and Drug Administration (FDA).

Dosage 105
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Transpire Bio signs with Recipharm for inhaled medicine development

European Pharmaceutical Review

Transpire Bio and Recipharm have signed a definitive agreement for the development of TRB-1 and TRB-2 – two inhaled medicines for the treatment of asthma and Chronic Obstructive Pulmonary Disease (COPD). TRB-1 and TRB-2 are the first products developed by Transpire Bio and are intended for advanced markets.

Dosage 105