Approvals (FDA, Total)
07-20-2010 |
12:54 hs.
Mylan Inc. announced that the Food and Drug Administration cleared generic version of Boehringer Ingelheim GmbH drug, Catapres-TTS, indicated to treat high-blood pressure.
07-13-2010 |
19:56 hs.
Protalix Biotherapeutics Inc. announced that the Food and Drug Administration will finally review Gauchers syndrome drug, Uplyso (Taliglucerase Alfa) on Ferbruary 2011. The drug has orphan drug status and Fast Track.
07-13-2010 |
19:46 hs.
Food and Drug Administration officials announced that Vivus Inc. oral obesity drug, Qnexa (Phentamine + Topiramate) showed to be effective but are concerned about safety. A July 15th. panel will decide if they recommend or not its approval.
07-13-2010 |
19:33 hs.
Bristol-Myers Squibb Co. Announced that the Food and Drug Administration accepted to review the supplemental New Drug Application for Sprycel (Dasatinib) drug, indicated to treat adults with newly diagnosed chronic myeloid leukemia (CML). The drug also received priority status review.
Second line treatment
07-07-2010 |
18:20 hs.
Roche Holding AG submitted for Food and Drug Administration approval, experimental drug to treat advanced HER2+ breast cancer drug, Trastuzumab DM1
07-07-2010 |
14:37 hs.
India based Caraco Pharmaceutical Laboratories Ltd. Announced that the Food and Drug Administration cleared generic sale of Meda Pharmaceuticals drug, Optviar, indicated to treat itching of the eyes associated with allergic conjunctivitis.
07-06-2010 |
20:58 hs.
Par Pharmaceuticals Inc. announced that it´s division Strativa Pharmaceuticals was cleared by the Food and Drug Administration for generic of GlaxoSmithKline Plc. drug Zofran (Ondasetron) to prevent nausea and vomiting in patients with cancer.
07-04-2010 |
21:15 hs.
Watson Pharmaceuticals Inc. announced that the Food and Drug Administration cleared generic version of Astellas Pharma Inc. drug, Prograf. Indicated to prevent rejection of kidney, liver or heart transplants.
07-04-2010 |
20:38 hs.
The Food and Drug Administration cleared India-based Sun Pharmaceuticals Industries to sell Novartis AG generic version of Exelson, indicated to treat Alzeheimer.
06-29-2010 |
19:50 hs.
Teva Pharmaceuticals Industries Ltd. was cleared by the Food and Drug Administration for generic version of AstraZeneca Plc. drug, Arimidex, indicated to treat postmenopausal women with certain types breast cancer.
Roche Holding AG Drug
06-27-2010 |
14:05 hs.
The Food and Drug Administration cleared Roche Holding AG injectable eye drug, Lucentis (Rabinizumab), to treat of macular oedema following retinal vein occlusion (RVO). The drug has been approved for macular degeneration for several years.
Asthma drug for patients older than 12
06-27-2010 |
13:54 hs.
Merck & Co. announced that the Food and Drug Administration cleared inhalation aerosol drug, Dulera (Mometasone + Formoterol) indicated to treat asthma in patients 12 years and older.
06-23-2010 |
14:59 hs.
The Food and Drug Administration cleared Bayer AG drug, Staxyn, a new version of Levitra (Vardenafil) indicated to treat erectile dysfunction.
06-23-2010 |
14:55 hs.
APP Pharmaceuticals Inc., a wholly owned subsidiary of Fresenius Kabi Pharmaceuticals Holding, Inc. said that the Food and Drug Administration cleared generic version of injectable antibiotic of Bristol-Myers Squibb Co. Azactam.
Chronic myeloid leukemia
06-21-2010 |
17:25 hs.
The Food and Drug Administration approved Novartis AG to market Tasigna (Nilotinib) was cleared as a treatment for patients newly diagnosed with chronic myeloid leukemia. The drug is already approved as a treatment for patients with chronic myeloid leukemia who received a prior treatment.
06-21-2010 |
17:13 hs.
Mylan Inc. announced that its subsidiary Matrix Laboratories Limited has received final approval for Merck & Co.generic drug, Zocor.
Advanced prostate cancer chemotherapy
06-21-2010 |
17:04 hs.
Sanofi-Aventis SA announced that the Food and Drug Administration cleared chemotherapy drug for advanced prostate cancer, Jevtana (cabazitaxel)
Avodart and Flomax Combination
06-17-2010 |
20:29 hs.
GlaxoSmithKline Plc. said that the Food and Drug Administration cleared Jalyn drug (Dutasteride + Tamsulosin), a product that combines Boehringer Ingelheim GmbH and Astellas Pharma Inc. Avodart with Flomax . The drug is indicated to treat symptomatic benign prostatic hyperplasia, or BPH.
06-15-2010 |
17:34 hs.
Strides Arcolab Ltd. announced that the Food and Drug Administration cleared migraine generic version of GlaxoSmithKline Plc. injection, Imitrex.
06-08-2010 |
20:24 hs.
Human Genome Sciences Inc. submitted for the European Medicines Agency approval, biologic drug, Benlysta (Belimumab) indicated to treat systemic lupus erythematosus. The drug is being developed jointly with GlaxoSmithKline Plc. and will be submitted for FDA approval during the 2Q 2010.


