• The US Food and Drug Administration (FDA) has approved AstraZeneca's Iressa (gefitinib) tablets, 250mg once daily, for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations, as detected by an FDA-approved test.

  • US Food and Drug Administration (FDA) has granted marketing authorisation for morphine sulfate ER tablets. A subsidiary of Zydus Pharmaceuticals (USA) Inc., Nesher has considerable expertise in niche therapies with development or products barriers, such as controlled release medications and DEA-controlled substances. Morphine sulfate ER tablets used in the treatment of chronic pain or cancer related pain. The product will be manufactured at Nesher Pharmaceuticals (USA) LLC, located at St. Louis, USA.

  • Jubilant Life Sciences has announced that it had received approval of the US Food and Drug Administration (FDA) for its tablets used in treating adults for various infections, including pneumonia. The market size for Levofloxacin is estimated to be $28 million (Rs.179 crore) per annum.

  • Wockhardt has received final approval from the US FDA for marketing 5mg/5ml of oxycodone HCI liquid. The company is launching the product soon and will be amongst the few generic versions of this product in the market.

  • Aurobindo Pharma got final approvals from the US FDA of azithromycin for injection USP, 500mg /vial and entacapone tablets. Azithromycin for injection USP, 500mg/vial is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Zithromax (azithromycin for injection) 500mg/vial of Pfizer, Inc. Azithromycin for injection, USP is a macrolide antibacterial drug indicated for the treatment of patients with infections caused by susceptible strains of the designated microorganisms in the conditions such as community-acquired pneumonia and pelvic inflammatory disease.

  • The US Food and Drug Administration (FDA) has accepted for review Teva Pharmaceutical's Biologics License Application (BLA) for reslizumab for the treatment of inadequately controlled asthma in adult and adolescent patients with elevated blood eosinophils, despite an inhaled corticosteroid (ICS)-based regimen.

  • The US Food and Drug Administration (FDA) has approved Novartis' Promacta (eltrombopag) for the treatment of children six years and older with chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy. Promacta was approved by the FDA in 2008 for use in adult patients with the same condition.

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