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Nastech Pharmaceuticals has received a “not approvable” letter from the FDA for its abbreviated new drug application (ANDA) for a generic nasal treatment for osteoporosis was rejected by the FDA, the company said June 13.
The FDA has rescinded approval of Par Pharmaceutical's abbreviated new drug application (ANDA) for a generic version of GlaxoSmithKline's (GSK) anti-nausea treatment Zofran ODT.
Andrx plans to meet with the FDA on Dec. 14 to discuss manufacturing issues that have stalled the company's drug approvals, Andrx said in a recent filing with the Securities and Exchange Commission (SEC).
Par Pharmaceutical's wholly owned subsidiary Kali Laboratories has received final FDA approval for its abbreviated new drug application (ANDA) for ondansetron HCl orally disintegrating tablets (ODT) in 4- and 8-mg dosage strengths.
Anchen Pharmaceuticals has received tentative approval from the FDA for its generic version of Biovail's extended-release antidepressant Wellbutrin XL (bupropion HCl) in 150- and 300-mg dosages.
The FDA’s Office of Generic Drugs (OGD) has launched its Dissolution Methods Database aimed at improving the quality and turnaround time of abbreviated new drug applications (ANDAs).
Impax has counter-sued Shire Pharmaceuticals, which in October launched the latest in a string of patent infringement lawsuits against Impax over its plans to launch a generic version of Shire’s attention deficit hyperactivity disorder (ADHD) drug Adderall XR.
In what one analyst called a “significant negative” for beleaguered Andrx, a federal court has granted Abbott Laboratories a preliminary injunction against Andrx and Ranbaxy Laboratories marketing their versions of Biaxin XL.
AstraZeneca has initiated a patent infringement lawsuit challenging Teva Pharmaceutical’s bid to launch a generic version of AstraZeneca’s blockbuster schizophrenia treatment Seroquel (quetiapine fumarate).