Generic

Acella Pharmaceuticals Attains Approval for Generic Gabapentin Oral Solution

The company has received FDA approval for its generic equivalent of a popular epilepsy drug.

Acella Pharmaceuticals, LLC, a specialty pharmaceutical company, announces the approval of an Abbreviated New Drug Application (ANDA) for Gabapentin Oral Solution, 250 mg/5 mL. The Food and Drug Administration (FDA) determined that Acella's ANDA is bioequivalent – therefore, therapeutically equivalent – to the reference listed drug, Neurontin Oral Solution, 250 mg/5 mL.

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Congressmen Call for Fairness in Generic Drug Approval Process

Two Representatives have introduced a bill that would streamline the Federal food, Drug and Cosmetic Act to streamline approval of low-cost generic drugs.

WASHINGTON, D.C.--Congressman Frank Pallone (D-NJ) and Congressman Brett Guthrie (R-KY) introduced the Generic Drug Application Review Fairness Act of 2012. The bill would make two important improvements to the Federal Food, Drug, and Cosmetic Act that will ensure continued access to high quality, low-cost generic medicines. Generic medicines, which account for nearly 80 percent of all U.S. prescriptions, saved the nation's health care system $931 billion between 2001 and 2010.

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FDA OKs Dr. Reddy's Generic Version of Arixtra

The Associated Press
Federal regulators approved a generic version of a blood-clot treatment made by Dr. Reddy's Laboratories, the company said Wednesday.
Dr. Reddy's, based in India, said the approval covers several doses of the fondaparinux sodium injection in prefilled, color-coded single-dose syringes.
It is a generic version of the GlaxoSmithKline blood-clot treatment, Arixtra.

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