Us Fda Approvals In 2010


Published on

USFDA Approvals, 2010

  • Be the first to comment

  • Be the first to like this

No Downloads
Total Views
On Slideshare
From Embeds
Number of Embeds
Embeds 0
No embeds

No notes for slide

Us Fda Approvals In 2010

  1. 1. US FDA APPROVED DRUGS, 2010   Date of  Name of the  Approval,  Brand  Molecule  Companies   2010  Indication  Summary  Ampyra Dalfampridine Acorda Therapeutics 22-Jan Multiple sclerosis Acorda's MS drug focused on helping patients' walking difficulties, and according to the company, is the only drug that can increase walking speeds in those affected. The drug's approval sparked almost immediate buyout rumors for Acorda. Although none came to fruition, the company has a manufacturing deal with Elan for the drug Asclera Polidocanol Chemische Fabrik 30-Mar Varicose veins The FDA approved Chemische Fabrik Kresussler's drug in March for Kresussler spider veins (varicose veins smaller than 1 mm in diameter) and reticular veins (those 1 to 3 mm in diameter) in March. The drug attacks the vein's cellular wall lining, causing the vessel to close Carbaglu Carglumic acid Orphan Europe 18-Mar NAGS deficiency Despite early concerns that study designs could have interfered with drug testing results, the FDA unanimously approved Carbaglu for patients with N-acetylglutamate synthase, or NAGS, deficiency, which causes excess amounts of ammonia in the blood. The drug is a Carbamoyl Phosphate Synthetase 1 activator Egrifta Tesamorelin Theratechnologies 10-Nov HIV Egrifta was approved to treat lipodystrophy, a condition common in those taking antiretroviral drugs to treat HIV. Lipodystrophy causes excess fat buildup particularly in the abdominal region. The growth hormone releasing factor (GRF) drug is administered via a daily injection, and was more effective than a placebo injection in clinical trials EllaOne Ulipristal acetate HRA Pharma, Watson 13-Aug Emergency Billed as the new "morning-after pill," EllaOne. Like Plan B, the pill is contraceptive taken after intercourse to reduce the risk of pregnancy, but EllaOne has a five-day window instead of Plan B's three-day effective period. EllaOne received a unanimous endorsement by the FDA advisory panel one month before its approval Gilenya Fingolimod Novartis 21-Sep Multiple sclerosis As the first oral MS drug, Novartis expects blockbuster results from Gilenya, estimating annual sales at up to $3.5 billion in an $11 billion- per-year market. The immunomodulator's next oral competitor is Merck KGaA's cladribine, which will be reviewed by Feb. 28, 2011 ManasRanjan Rout, New Delhi (
  2. 2. US FDA APPROVED DRUGS, 2010   Halaven Eribulin mesylate Eisai 15-Nov Breast cancer Just as its Alzheimer's drug Aricept was coming off patent, Eisai garnered FDA approval for its third-line breast cancer drug, Halaven. The microtubule inhibitor injectable is a synthetic version of a compound derived from a sea sponge. Patients receiving the treatment should have gone through two types of chemotherapy to combat breast cancer Jevtana Cabazitaxel Sanofi-Aventis 17-Jun Prostate cancer Sanofi's microtubule inhibitor injection was approved by the FDA as a second-line treatment for metastatic hormone-refractory prostate cancer. The drug is used in conjunction with prednisone after patients have undergone docetaxel-based chemotherapy Krystexxa Pegloticase Savient 14-Sep Gout After a year of FDA woes, Savient's gout biologic Krystexxa gained Pharmaceuticals approval in September. In July 2009, the second-line drug was rejected by the FDA over manufacturing concerns, which sent Savient's shares spiraling. In October, the company hit another snag after it had trouble raising the money needed to launch Krystexxa Lastacaft Alcaftadine Johnson & Johnson, 28-Jul Itching J&J and Allergan's eye solution was approved by the FDA for itching ophthalmic solution Allergan associated with associated with conjunctivitis in patients older than two years. The pink eye recommended dosage is one drop per eye per day Latuda Lurasidone HCl Dainippon Sumitomo 28-Oct Schizophrenia In October, the FDA approved another schizophrenia treatment, Dainippon Sumitomo's Latuda. In four six-week studies, the drug performed better than a placebo in reducing schizophrenic symptoms. Like all other atypical antipsychotics, Latuda is not approved for treatment of dementia-related psychosis Lumizyme Alglucosidase alfa Genzyme 24-May Pompe disease After two rejections, Genzyme received FDA approval for its late-onset Pompe disease drug, Lumizyme. The gene mutation causes heart, skeletal and respiratory weakness, leading to respiratory failure and death. Lumizyme replaces the acid alpha-glucosidase (GAA) and reduce glycogen in the heart and muscle. The drug was approved with REMS, restricted distribution and a warning of anaphylaxis, severe allergic reactions and immune-mediated reactions Natazia Estradiol valerate Bayer 7-May Contraceptive The first four-phasic birth control pill, Natazia, was aproved on May 7. and estradiol Bayer's newest female oral contraceptive delivers both estrogen and valerate/dienogest progestin in four varying amounts over the 28-day cycle ManasRanjan Rout, New Delhi (
  3. 3. US FDA APPROVED DRUGS, 2010   Pradaxa Dabigatran etexilate Boehringer Ingelheim 19-Oct Atrial fibrillation In the race for the bloodthinner warfarin's replacement, Boehringer took mesylate an early lead with Pradaxa's approval. Analysts believe the drug could produce $1.3 billion in revenue per year, but its competitors could come along soon: namely J&J's Xarelto and the BMS/Pfizer partner drug apixaban Prolia Denosumab Amgen 1-Jun Osteoporosis Only days after receiving European approval, and almost two months ahead of schedule, Amgen's postmenopausal osteoporosis treatment, Prolia, was approved by the FDA. The drug is administered via twice- annually injections. "We're not trying to go out there and take business away from existing drugs... but we recognize that this is a very unsatisfied group of patients that need other options," Roger Perlmutter, Amgen's EVP of research and development, told the Wall Street Journal Teflaro Ceftaroline fosamil Forest Laboratories 29-Oct Skin infections, Infection fighters have a new ally in Forest Lab's injectable antibiotic bacterial Teflaro. The cephalosporin was approved to treat community acquired pneumonia bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections, including methicillin-resistant Staphylococcus aureus (MRSA). Many of these serious infections are more common in healthcare settings and are resistant to more common antibiotics Victoza Liraglutide Novo Nordisk 25-Jan Diabetes Six after winning approval in Europe, U.S. regulators gave the okay to Novo Nordisk's potential blockbuster type II diabetes drug Victoza. The drug is an improvement over traditional therapies in that tt doesn't risk pushing blood sugar too low and promotes weight loss in patients. However, the FDA was spooked by animal data that demonstrated Victoza was linked to a greater risk of tumors, which contributed to a 21-month review process. Though Victoza's label will carry a warning for the increased risk of thyroid cancer, analysts still expect sales of the drug to peak at around $1.33 billion annually Vpriv Velaglucerase alfa Shire Pharmaceuticals 26-Feb Gaucher disease With Genzyme's Gaucher disease drug Cerezyme sidelined by manufacturing issues, Shire raced to regulators with its own Gaucher's treatment. And after winning approval the company set its sights on permanently wresting control of the disease market from Genzyme. Shire priced Vpriv 15 percent below Genzyme's $200,000 asking price for Cerezyme--an attractive option for insurers who'd like to save $30,000 on treating those with the rare disease ManasRanjan Rout, New Delhi (
  4. 4. US FDA APPROVED DRUGS, 2010   Xeomin IncobotulinumtoxinA Merz Pharmaceuticals 30-Jul Uncontrolled According to Merz, more than 84,000 patients have been treated with muscle Xeomin worldwide since 2005. And last summer, the U.S. joined 19 contractions other countries to have approved the product for the treatment of cervical dystonia and blepharospasm. Xeomin is the only botulinum toxin that does not require refrigeration prior to reconstitution, and Merz believes this may simplify product distribution and storage and ensure product integrity at the time of injection Xiaflex Collagenase Auxilium 2-Feb Depuytren's Auxilium Pharmaceuticals won the unanimous backing of an FDA clostridium Pharmaceuticals contracture advisory panel for its experimental therapy to treat Dupuytren's histolyticum contracture back in the fall 2009. Roughly 7 million to 14 million people suffer from Dupuytren's disease, a buildup of collagen that leaves fingers bent with patients unable to extend them normally. "We believe the approval of Xiaflex represents a major breakthrough for patients suffering from the debilitating effects of Dupuytren's contracture," says Auxilium CEO Armando Anido. Last winter, Auxilium scored a $15 million milestone from Pfizer, which holds the rights to sell the drug in Europe. This week, Auxilium announced its Q4 financial results-and boasted of promising Xiaflex sales and the potential for an expanded indication. "We ...launched XIAFLEX in the U.S. for Dupuytren's contracture, received a positive CHMP opinion with our EU partner, Pfizer, for XIAFLEX for Dupuytren's contracture, and initiated XIAFLEX global phase III clinical trials for Peyronie's disease," Anido says in a release. "As we look forward to 2011 and beyond, we ... believe that the potential global market for XIAFLEX represents a blockbuster opportunity, which could provide sustainable long-term growth for the Company."       ManasRanjan Rout, New Delhi (
  1. A particular slide catching your eye?

    Clipping is a handy way to collect important slides you want to go back to later.