Spanish drug maker Almirall and US-Based Johnson & Johnson Inc. announced that the Food and Drug Administration cleared migraine drug Axert (Almotriptan) to be used in adolescents.

The drug also known as Almogran, had global sales of 19.5 million dollars during the 1Q of 2009.

It was informed officially, that it is the first drug of the 5HT3 family to be approved for treatment in non-adult patients.
In the United States, the J&J unit, Ortho McNeil Janssen Pharmaceuticals is in charge of its marketing. The drugs patent will expire by November 2015.

US-Based Eli Lilly & Co. announced a new presentation to the Food and Drug Administration, for an extended use of blockbuster Cymbalta (Duloxetine) to treat chronic pain. Last year the Indianapolis-based drug maker submitted and later withdrew application for that condition.

Swiss Novartis AG announced that the Food and Drug Administration authorized marketing of blockbuster Gleevec to be used after surgery reducing risk of relapse on patients with gastrointestinal stromal tumor (GIST). Gleevec is currently used as a treatment for leukemia and gastrointestinal tumors.

Indiana-based Eli Lilly & Co. withdrew its application for U.S. regulatory approval of its Cymbalta (duloxetine) depression treatment for use as chronic-pain medicine. The company plans to resubmit the application next year.

CV Therapeutics announced the Food and Drug Administration had approved their chronic angina drug Ranexa (ranolazine extended-release tablets) as a first-line treatment – it was previously approved for patients with that condition but had no success with other medications.

AstraZeneca announced that the U.S. Food and Drug Administration has approved Seroquel XR (Extended-Release) tablets for the acute treatment of the depressive episodes associated with bipolar disorder, the manic and mixed episodes associated with bipolar I disorder, and the maintenance treatment of bipolar I disorder.

The Food and Drug Administration has granted approval to a new dose of Bristol-Myers Squibb´s HIV drug Reyataz in combination with other medicines.

Eli Lilly and Co announced it has won the Food and Drug Administration approval for its drug Alimta as a first-line treatment for patients with advanced non-small cell lung cancer.

Johnson & Johnson has filed an sNDA (supplemental new drug application) with the U.S. Food and Drug Administration (FDA) for approval to market its ovarian cancer drug Doxil in combination with Sanofi-Aventis SA´s Taxotere, for treatment of women with advanced breast cancer who have already received treatment.

The FDA has accepted the complete response submitted by Canadian drugmaker Labopharm, providing additional analysis of existing data on its once-daily version of painkiller Tramadol. The acceptance paves the way to an approval, expected by early 2009

Eli Lilly & Co. announced the U.S. Food and Drug Administration (FDA) has approved its new use application for Cymbalta (duloxetine HCl), for the management of fibromyalgia, a chronic widespread pain disorder. Cymbalta is currently approved for the management of diabetic peripheral neuropathic pain (DPNP), the treatment of major depressive disorder and generalized anxiety disorder, all in adults. It does not have pediatric approval.

AstraZeneca submitted its once-daily Seroquel XR extended-release tablets to European Union regulators for the treatment of major depressive disorder (MDD). This follows a sNDA submission for the blockbuster atypical antipsychotic medication in the U.S. last February. Each year, 33 million Europeans are estimated to suffer from MDD

The U.S Food and Drug Administration (FDA) has broadened the U.S. indication for once-yearly Reclast - Aclasta in Europe - (zoledronic acid) Injection 5 mg for osteoporosis to include the prevention of new clinical fractures in patients who have recently undergone a low-trauma hip fracture. The decision was based on safety and efficacy trial data published in the New England Journal of Medicine.

Astra has filed a supplemental New Drug Application to the U.S. FDA covering use of its asthma drug Symbicort in children from 6 years old up. The Anglo-Swedish drugmaker aims to grab market share from competition: Glaxo’s blockbuster Advair

Anglo-Swedish pharmaceutical giant, AstraZeneca, has filed a supplemental New Drug Application with the FDA to market Nexium I.V., esomeprazole sodium injection, for the management of peptic ulcer bleeding, following therapeutic endoscopy. The application is based on Astra’s Nexium I.V. Peptic Ulcer Bleed study

Anglo-Swedish drugmaker AstraZeneca submitted an sNDA to the FDA for its schizophrenia drug Seroquel XR for the treatment of generalised anxiety disorder (GAD). If approved, AstraZeneca’s product would become the first atypical antipsychotic medication in the market for GAD

A Joint Advisory Committee to the FDA voted not to endorse approval of an expanded label for Cephalon’s potent opioid analgesic Fentora for the management of severe flares of pain in non-cancer patients who are tolerant to opioid therapy. The panel said it wants to minimize risks associated with an expanded use of Fentora and prevent opioid abuse