PHARMACY

FDA issues final guidance on generic drug appearance

BY Michael Johnsen

WASHINGTON — The Food and Drug Administration recently issued its final guidance on the appearance of generic pharmaceuticals, recommending drugs made by generic manufacturers closely mimic the physical attributes, including the size, shape and color, of the drugs they reference.
 
(To view the full Category Review, click here.)
 
"[We] are concerned that differences in physical characteristics (e.g., size and shape of the tablet or capsule) may affect patient compliance and acceptability of medication regimens or could lead to medication errors," FDA wrote in its guidance. "We believe these patient safety concerns are important, and we are recommending that generic drug manufacturers consider physical attributes when they develop quality target product profiles for their generic product candidates."
 
FDA also recommended generic drugs not be larger than any drug already equal to or greater than 17 mm in its largest dimension. Products should also be of a similar shape to the reference drug, and have other physical similarities which make it as easy to swallow as the original. For example, a product's weight, surface area, tablet coating and disintegration time should all be similar.
 
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Sandoz launches Glatopa as first U.S. Copaxone generic

BY David Salazar

HOLZKIRCHEN, Germany — Sandoz has launched Glatopa, the first U.S. generic of Teva’s Copaxone (glatiramer acetate injection, 20-mg/ml ), a once-daily treatment for multiple sclerosis. The drug was developed in collaboration with Momenta and approved by the FDA in April. 

“Sandoz, together with Momenta, is proud to announce the US market launch of a fully substitutable generic version of this important therapy, following FDA approval,” Sandoz U.S. President Peter Goldschmidt said.

The company is also introducing a patient support service that includes financial assistance for qualifying patients, injection training, and access to nurses for non-clinical questions 24 hours a day. 

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FDA approves new indication for Eisai’s Fycompa

BY David Salazar

WOODCLIFF LAKE, N.J. — Eisai announced Monday that the Food and Drug Administration had given the company approval for a new indication for its seizure treatment Fycompa. The medication has been approved as an adjunctive therapy in treating primary generalized tonic-clonic seizures (PGTC). 

The approval of FYCOMPA to treat patients age 12 and older with PGTC seizures represents an important next step toward expanding treatment options for patients whose PGTC seizures are not adequately controlled with their current medication,” Lynn Kramer Eisai’s chief clinical officer and president of Eisai’s Neuroscience and General Marketing Unit, said. “Eisai is committed to advancing epilepsy care and making contributions to help address the diversified needs of epilepsy patients and their families as part of its corporate humane healthcare mission.”

Fycompa is available in 2-, 4-, 6-, 8-, 10- and 12-mg dosage strengths, and patients who are eligible can register at Fycompa.com for a Fycompa savings card.

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