New Drug Products of 2010

Actemra

Indication(s): Moderately-to severely-active rheumatoid arthritis in patients who have had an inadequate response to ≥1 TNF blocker. May be used with methotrexate or DMARDs.
Ampyra

Indication(s): To improve walking in patients with multiple sclerosis (demonstrated by an increase in walking speed).
Bepreve

Indication(s): Treatment of itching due to allergic conjunctivitis.
Beyaz

Indication(s): Oral contraception. Premenstrual dysphoric disorder (PMDD) in women who choose an oral contraceptive for contraception. Moderate acne vulgaris in women ≥14 years old who choose an oral contraceptive for contraception. To raise folate levels in women who choose to use an oral contraceptive for contraception.
Dulera

Indication(s): Maintenance treatment of asthma in patients not adequately controlled on other asthma-controller medications or whose disease severity warrants initiation of both an inhaled steroid and a long acting β2-agonist.
Exalgo

Indication(s): Moderate to severe pain when continuous opioid analgesia is needed for an extended time period. Not for as-needed use or to treat acute or post-op pain. For use in opioid-tolerant patients only.
Fanapt

Indication(s): Acute treatment of schizophrenia.
Gilenya

Indication(s): For relapsing forms of multiple sclerosis (MS): to reduce the frequency of clinical exacerbations and to delay the accumulation of physical disability.
Iprivask

Indication(s): DVT prophylaxis in patients undergoing hip replacement surgery.
Jalyn

Indication(s): Benign prostatic hyperplasia (BPH).
$Indication(s): Chronic gout in adult patients refractory to conventional therapy.$

Krystexxa

Indication(s): Chronic gout in adult patients refractory to conventional therapy.
Livalo

Indication(s): Adjunct to diet: To reduce elevated total-C, LDL-C, ApoB, and TG, and to increase HDL-C in primary hyperlipidemia and mixed dyslipidemia.
Lysteda

Indication(s): Cyclic heavy menstrual bleeding.
Menveo

Indication(s): Meningitis immunization.
Oravig

Indication(s): Local treatment of oropharyngeal candidiasis.
Pradaxa

Indication(s): To reduce risk of stroke and systemic embolism in non-valvular atrial fibrillation.
$Indication(s): In postmenopausal women with osteoporosis: at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other therapy; to reduce incidence of vertebral, nonvertebral, and hip fractures.$

Prolia

Indication(s): In postmenopausal women with osteoporosis: at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other therapy; to reduce incidence of vertebral, nonvertebral, and hip fractures.
Qutenza

Indication(s): Management of neuropathic pain associated with post-herpetic neuralgia.
Rybix ODT

Indication(s): Moderate to moderately severe pain in adults.
Saphris

Indication(s): For the acute treatment of: 1) schizophrenia; 2) manic or mixed episodes associated with bipolar I disorder.
Tekamlo

Indication(s): Hypertension.
Tribenzor

Indication(s): Hypertension. Not for initial therapy.
Vibativ

Indication(s): Complicated skin and skin structure infections due to susceptible gram (+) bacteria.
Victoza

Indication(s): As adjunct to diet and exercise, to improve glycemic control in type 2 diabetes.
Vimovo

Indication(s): Osteoarthritis, rheumatoid arthritis, ankylosing spondylitis: to improve symptoms and reduce risk of gastric ulcers in patients at risk of developing NSAID-associated gastric ulcers.
Xifaxan 550mg

Indication(s): Reduction in risk of overt hepatic encephalopathy (HE) recurrence in patients ≥18 years of age.
Zenpep

Indication(s): Exocrine pancreatic insufficiency (eg, cystic fibrosis).
Zyclara

Indication(s): Actinic keratoses on face and balding scalp in immunocompetent patients.
Silenor

Indication(s): Treatment of insomnia characterized by difficulty with sleep maintenance.
Cayston

Indication(s): To improve respiratory symptoms in cystic fibrosis (CF) patients with Pseudomonas aeruginosa.
Natazia

Indication(s): Oral contraception.