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Amide Pharmaceutical has received final approval from the FDA for its abbreviated new drug application (ANDA) for mirtazapine orally disintegrating tablets (ODT) in 15-, 30- and 45-mg dosage strengths.
The FDA has approved Merck's biologics license application for Proquad, a combination vaccine for simultaneous vaccination against measles, mumps, rubella (German measles) and varicella (chickenpox) in children 12 months to 12 years of age.
Chugai Pharmaceutical will begin releasing information on clinical trials conducted by the company through a website organized by the Japan Pharmaceutical Information Center.
Lipid Sciences has completed its exploratory investigation of the therapeutic effect of delipidated autologous virus in chronically Simian Immunodeficiency Virus (SIV)-infected rhesus macaques.
ISTA Pharmaceuticals has announced the publication of the pooled safety and efficacy findings of the company's two randomized, double-masked, placebo-controlled Phase III studies of Vitrase (ovine hyaluronidase) for the management of vitreous hemorrhage, a serious condition affecting the back of the eye for which there is currently no drug treatment.
Indevus Pharmaceuticals has initiated a Phase III clinical program for Sanctura XR in patients with overactive bladder. Sanctura XR is the once-daily formulation of Sanctura, which is currently being marketed in the U.S.
DURECT, an emerging specialty pharmaceutical company, announced that Pain Therapeutics has achieved positive Phase III clinical results for Remoxy, a novel long-acting, abuse-deterrent oral formulation of oxycodone based on DURECT's Oradur technology.
Join FDAnews Monday, Sept. 12, for a 90-minute audioconference on "Trends in Fraud and Abuse Enforcement: Ensure Compliance for Your Promotions." Learn from Paul Kalb and Ted Acosta how to effectively promote your products in compliance with federal regulations. Gain insights on enforcement developments and drug promotion issues as well as tips on making informed decisions when developing a sales and marketing compliance program. On Sept. 14, join FDAnews for "Drug Safety in the EU: Understand the Requirements and Regulations That Affect You." Discover what you need to know about drug safety to operate in the EU. Learn from expert Linda Horton about the relevant requirements, recent initiatives and upcoming changes that affect
drug safety, and which agencies are key players and what their responsibilities are.