The latest FDA action (through August 2007) related to rimonabant (Zimulti), guanfacine extended-release (Intuniv), risperidone (Risperdal), maraviroc, sitaxsentan (Thelin), HCV-796, docetaxel (Taxotere Injection Concentrate), raltegravir (Isentress), topotecan (Hycamtin), ixabepilone, cetuximab (Erbitux), leukocyte interleukin (Multikine), pafuramidine, ALTU-135
NDA withdrawn
• Rimonabant (Zimulti , Sanofi-Aventis) for weight management in obese and overweight patients with associated risk factors
Approvable designations
• Risperidone (Risperdal, Janssen) for the treatment of schizophrenia in adolescents aged 13 to 17 years and for the short-term treatment of bipolar mania associated with bipolar I disorder in children and adolescents aged 10 to 17 years
• Maraviroc (Pfizer) as therapy for treatment-experienced patients infected with CCR5-tropic HIV-1
• Sitaxsentan (Thelin, Encysive) for the treatment of pulmonary arterial hypertension (PAH) (third approvable letter)
Fast-track designation
• HCV-796 (ViroPharma) for the treatment of hepatitis C virus (HCV) infection
Priority review
• Docetaxel (Taxotere Injection Concentrate, Sanofi-Aventis) in combination with cisplatin and fluorouracil for induction (neoadjuvant) therapy of patients with locally advanced squamous cell carcinoma of the head and neck prior to chemoradiotherapy and surgery
• Raltegravir (Isentress, Merck) in combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-experienced patients with evidence of HIV-1 replication despite ongoing antiretroviral therapy
• Topotecan (Hycamtin, GlaxoSmithKline) for the treatment of relapsed small cell lung cancer (SCLC)
• Ixabepilone (Bristol-Myers Squibb) as monotherapy for the treatment of metastatic or locally advanced breast cancer after failure of an anthracycline, a taxane, and capecitabine and in combination with capecitabine for the treatment of metastatic or locally advanced breast cancer after failure of an anthracycline and a taxane
• Cetuximab (Erbitux, ImClone Systems) for the treatment of patients with EGFR-expressing metastatic colorectal cancer whose disease has progressed following, or who were not candidates to receive, irinotecan- or oxaliplatin-based chemotherapy
Orphan drug designations
• Leukocyte interleukin (Multikine, CEL-SCI) as neoadjuvant therapy in patients with squamous cell carcinoma of the head and neck
• Pafuramidine (Immtech) for the treatment of malaria
Orphan drug designation revocation
• ALTU-135 (Altus) for the treatment of pancreatic insufficiency
Employers Face Barriers With Adopting Biosimilars
March 1st 2022Despite the promise of savings billions of dollars in the United States, adoption of biosimilars has been slow. A roundtable discussion among employers highlighted some of the barriers, including formulary design and drug pricing and rebates.