APP Pharmaceuticals receives FDA approval to advertise Ganciclovir for Injection.
APP’s Ganciclovir for Injection is usually AP-rated, latex-free and bar-coded. According to IMS Health, sales of this product for 2009 in the usa were around $13.5 million. Ganciclovir for Injection is an antiviral medication, which is used in the treating Cytomegalovirus retinitis in immunocompromised patients, including patients with acquired immunodeficiency syndrome , as well as for preventing CMV disease in transplant recipients at risk for CMV disease. CMV disease is certainly a serious illness that can result in blindness, transplant graft reduction and potential lack of life.The other, a far more unexpected switch at the helm, reveals a pharmaceutical giant with a fluctuating business strategy. Image: Newscom, Pfizer.. AcelRx Pharmaceuticals completes End-of-Phase 2 ending up in the FDA for its ARX-01drug/device AcelRx Pharmaceuticals, Inc. Today announced that it offers effectively completed an End-of-Phase 2 meeting with the FDA for ARX-01, a drug/device mixture product predicated on the business’s proprietary NanoTab dosage type, which allows delivery of sufentanil by the noninvasive oral transmucosal route. ARX-01 offers a non-invasive option to intravenous patient-managed analgesia for the management of severe post-operative pain in a healthcare facility setting. The FDA examined a package predicated on positive Phase 2 clinical study results from three Phase 2 trials which demonstrated the features of the ARX-01 device and the safety and efficacy of Sufentanil NanoTabs for the treatment of moderate-to-severe acute pain following knee replacement surgery and abdominal surgery.