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Precose and Reminyl are the latest drugs to receive abbreviated new drug applications (ANDAs) with Paragraph IV certifications against them, according to the FDA’s May 2 updated list of Paragraph IV filings.
Biovail Laboratories has filed a lawsuit in federal court against generic firm Impax over its bid to launch a generic version of Biovail’s Wellbutrin XL, an antidepressant marketed by GlaxoSmithKline.
A recent appeals court decision against Natural Biologics will force Barr to withdraw its pending abbreviated new drug application (ANDA) from the FDA for a generic version of Wyeth’s Premarin (conjugated estrogens tablets).
Even though the company has already been licensed by brand drugmaker Cephalon to manufacture and market a generic version of Actiq, generic firm Barr Laboratories filed an abbreviated new drug application (ANDA) with a paragraph IV early last month.
Drugmakers submitting abbreviated new drug applications should investigate whether the drug substance under consideration can exist in polymorphic forms — including crystalline and amorphous forms, as well as solvate and hydrate forms — according to a draft guidance released by the FDA.
Even though the company already has been licensed by brand drugmaker Cephalon to manufacture and market the product, generic firm Barr Laboratories has filed an abbreviated new drug application (ANDA) with a paragraph IV certification for a generic version of Actiq.
Generic firm Barr Laboratories has filed an abbreviated new drug application (ANDA) with a paragraph IV certification for a generic version of Actiq — even though the company already has been licensed by brand drugmaker Cephalon to manufacture and market the product.
Barr Laboratories, a subsidiary of Barr Pharmaceuticals, has filed an abbreviated new drug application (ANDA) to develop and market a generic version of Zyprexa orally dissolving tablets, a top-selling antipsychotic drug manufactured by Eli Lilly.
The FDA will not take action against firms that submit, via annual report, postapproval manufacturing changes made to comply with an official compendium, the agency announced in a guidance document.
The FDA has issued a question-and-answer draft guidance that clarifies changes made by the Medicare Modernization Act (MMA) in relation to the generic-drug approval process.