USFDA Approvals, 2010

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 (healthcaremanas@in.com)

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 (healthcaremanas@in.com)

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 (healthcaremanas@in.com)

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 (healthcaremanas@in.com)