Clinical Trial Resource Center


Clinical Trial Resource Center

FDA Approved Drugs for Musculoskeletal

Drugs Approved in 2014

Lemtrada (alemtuzumab); Genzyme; For the treatment of relapsing multiple sclerosis, Approved November 2014

Otezla (apremilast); Celgene; For the treatment of adults with active psoriatic arthritis, Approved March 2014

Plegridy (peginterferon beta-1a); Biogen IDEC.; For the treatment of relapsing multiple sclerosis, Approved August 2014

Targiniq ER (oxycodone hydrochloride + naloxone hydrochloride) extended-release tablets; Purdue Pharma; For the management of severe chronic pain, Approved July 2014

Vimizim (elosulfase alfa); BioMarin; For the treatment of Mucopolysaccharidosis type IVA, Approved February 2014

Drugs Approved in 2013

Actemra (ocilizumab); Genentech; For the treatment of Polyarticular Juvenile Idiopathic Arthritis, Approved May 2013

Duavee (conjugated estrogens/bazedoxifene); Pfizer; For the treatment of vasomotor symptoms associated with menopause and postmenopausal osteoporosis, Approved October 2013

Ilaris (canakinumab); Novartis; For the treatment of Systemic Juvenile Idiopathic Arthritis, Approved May 2013

Tecfidera (dimethyl fumarate); Biogen Idec; For the treatment of relapsing multiple sclerosis, Approved March 2013

Drugs Approved in 2012

Aubagio (teriflunomide); Sanofi Aventis; For the treatment of multiple sclerosis, Approved September 2012

Elelyso (taliglucerase alfa); Pfizer; For the treatment of Gaucher disease, Approved May 2012

Lyrica (pregabalin); Pfizer; For the treatment of neuropathic pain associated with spinal cord injury, Approved June 2012

Myrbetriq (mirabegron); Astellas Pharma US, Inc; For the treatment of overactive bladder, Approved June 2012

Neupro (Rotigotine Transdermal System); UCB; For the treatment of Restless Legs Syndrome, Approved April 2012

Rayos (prednisone) delayed-release tablets; Horizon Pharma; For the treatment of certain inflammatory diseases, including arthritis, COPD, asthma and psoriatic conditions, Approved July of 2012

Stendra (avanafil); Vivus; For the treatment of erectile dysfunction, Approved April 2012

Votrient (pazopanib); GlaxoSmithKline; For the treatment of soft tissue sarcoma, Approved April 2012

Xeljanz (tofacitinib); Pfizer; For the treatment of moderately to severely active rheumatoid arthritis, Approved November 2012

Drugs Approved in 2011

Actemra (tocilizumab); Genentech; For the treatment of systemic juvenile idiopathic arthritis, Approved April 2011

Duexis (ibuprofen and famotidine); Horizon Pharma; For the relief of rheumatoid arthritis and osteoarthritis and prevention of gastric ulcers, Approved April 2011

Drugs Approved in 2010

Actemra (tocilizumab); Genentech; For the treatment of rheumatoid arthritis, Approved January 2010

Ampyra (dalfampridine); Acorda; For the improvement of walking in patients with multiple sclerosis, Approved January 2010

Botox (onabotulinumtoxinA); Allergan; For the treatment of upper limb spasticity, Approved March 2010

Gilenya (fingolimod); Novartis; For the treatment of relapsing multiple sclerosis, Approved September 2010

Krystexxa (pegloticase); Savient Pharma; For the treatment of chronic gout (hyperuricemia), Approved September 2010

Prolia (denosumab); Amgen; For the treatment of postmenopausal women with osteoporosis at high risk for fracture, Approved June 2010

Vimovo (naproxen + esomeprazole); AstraZeneca; For the treatment of arthritis in patients at risk for NSAID-associated ulcers, Approved April 2010

Xeomin (incobotulinumtoxinA); Merz Pharmaceutical; For the treatment of cervical dystonia and blepharospasm, Approved July 2010

Xgeva (denosumab); Amgen; For the prevention of skeletal-related events in patients with bone metastases from solid tumors, Approved November 2010

Xiaflex (collagenase clostridium histolyticum); Auxilium Pharmaceuticals; For the treatment of Dupuytren’s contracture, Approved February 2010

Drugs Approved in 2009

Cimzia (certolizumab pegol); UCB; For the treatment of rheumatoid arthritis, Approved May of 2009

Colcrys (colchicine); Mutual Pharmaceuticals; For gout flares and familial Mediterranean fever, Approved October 2009

Extavia (Interferon beta-l b); Novartis; For the treatment of relapsing multiple sclerosis, Approved August of 2009

Pennsaid (diclofenac sodium topical solution); Nuvo Research; For the treatment of osteoarthritis of the knee, Approved November 2009

Sabril (vigabatrin); Lundbeck; For the treatment of infantile spasms and complex partial seizures, Approved August 2009

Savella (milnacipran hydrochloride); Forest Laboratories; For the treatment of fibromyalgia, Approved January 2009

Simponi (golimumab); Centocor Ortho Biotech; For the treatment of rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis, Approved April 2009

Drugs Approved in 2008

Orencia (abatacept); Bristol-Myers Squibb; For the treatment of Juvenile Idiopathic Arthritis, Approved April 2008

Xenazine (tetrabenazine); Prestwick Pharma; For the treatment of chorea due to Huntington's disease, Approved August 2008

Drugs Approved in 2007

Amrix (cyclobenzaprine hydrochloride extended release); Cephalon; For the treatment of muscle spasm associated with acute, painful musculoskeletal conditions, Approved February 2007

Evista (raloxifene hydrochloride); Eli Lilly; For the treatment/prevention of osteoporosis and reduction of breast cancer risk in postmenopausal women, Approved September 2007

Reclast (zoledronic acid); Novartis; For the treatment of Paget's disease, Approved April 2007

Reclast (zoledronic acid); Novartis; For the treatment of postmenopausal osteoporosis, Approved August 2007

Somatuline Depot (lanreotide acetate); Beaufour Ipsen; For the treatment of acromegaly, Approved August 2007

Drugs Approved in 2005

Boniva (ibandronate); Roche / GlaxoSmithKline; For the treatment and prevention of osteoporosis, Approved May, 2003 -- UPDATED: NEW FORMULATION APPROVED MARCH, 2005

Naglazyme (galsulfase); BioMarin Pharmaceuticals; For the treatment of mucopolysaccharidosis VI (Maroteaux-Lamy syndrome), Approved May 2005

Drugs Approved in 2004

Vioxx (rofecoxib); Merck; For the treatment of rheumatoid arthritis, Approved April 2002 -- UPDATED: WITHDRAWN OCTOBER 2004

Drugs Approved in 2003

Aldurazyme (laronidase); Genzyme; For the treatment of Mucopolysaccharidosis I (MPS I) in subjects aged 5 to 65, Approved May 2003

Premarin (conjugated estrogens); Wyeth; For the prevention of postmenopausal osteoporosis and treatment of vasomotor menopause symptoms, Approved July of 2003

Somavert (pegvisomant); Pharmacia & Upjohn; Injectable formulation for the treatment of acromegaly, Approved March 2003

Velcade (bortezomib); Millennium Pharmaceuticals; Injectable agent for the treatment of multiple myeloma patients who have received at least two prior therapies., Approved May 2003

Drugs Approved in 2002

Alora; Watson Pharmaceuticals; Transdermal patch for the prevention of postmenopausal osteoporosis and treatment of vasomotor menopausal symptoms, Approved April 2002

Avinza (morphine sulfate); Elan Pharmaceuticals; Extended release capsule for the relief of pain requiring continuous, around-the-clock therapy, Approved March 2002

Forteo (teriparatide); Eli Lilly; For the treatment of Osteoporosis in postmenopausal women and men who are at high risk for a fracture., December 2002

Remicade (infliximab); Centocor Ortho Biotech; Intravenous infusion for the treatment of rheumatoid arthritis, Approved February 2002

Testim; Auxilium Pharmaceuticals; External cream for the treatment of male hormone deficiency., Approved October 2002

Vivelle-Dot (estradiol transdermal system); Novartis; For the prevention of post-menopausal osteoporosis, Approved May 2002

Drugs Approved in 2001

Genotropin (somatropin) injection; Pharmacia & Upjohn; For the treatment of growth failure in children who were born small for gestational age (SGA), Approved July 2001

Kineret; Amgen; Injectable therapy for the treatment of rheumatoid arthritis, Approved November 2001

Supartz; Smith & Nephew Orthopaedics; Joint fluid therapy for treatment of osteoarthritis in the knee, Approved January 2001

Drugs Approved in 2000

Activella (Estradiol/Norethindrone Acetate) Tablets; Novo Nordisk; Combination hormone replacement therapy for the prevention of osteoporosis and other symptoms associated w/postmenopause, Approved April 2000

Mobic (meloxicam) Tablets; Boehringer Ingelheim; For relief of the signs and symptoms of osteoarthritis, Approved April 2000

Myobloc; Elan Pharmaceuticals; Injectable solution for the treatment of abnormal head position and neck pain associated with cervical dystonia, Approved December 2000

Drugs Approved in 1999

Evista (raloxifene hydrochloride); Eli Lilly; Osteoporosis treatment, Approved September 1999

Femhrt Tablets; Parke-Davis; Norethindrone acetate (1mg) and ethinyl estradiol tablets (5mcg), October 15, 1999

Drugs Approved in 1998

Actonel; Procter & Gamble, Hoechst Marion Roussel; Treatment for Paget's Disease, Approved April 1998

Estratab (.3 mg ); Solvay Pharmaceuticals; Treatment for the prevention of osteoporosis, Approved March 1998

Etodolac; Faulding; Generic equivalent of Lodine 500 mg tablets, Approved May 1998

Lodine XL (etodolac); Wyeth; Treatment for arthritis, Approved February 1998

Lovenox (enoxaparin sodium) Injection; Rhone Poulenc Rorer; Treatment for prevention of blood clots following hip-replacement surgery, Approved February 1998

Drugs Approved in 1997

Arthrotec; Searle; Treatment for arthritis, Approved December 1997

Atracurium Besylate Injection; Faulding; Generic equivalent of Tracrium, Approved April 1997

Estradiol tablets; Barr Laboratories; Generic equivalent of Estrace, Approved October 1997

Etodolac; Royce Laboratories; Generic equivalent of Lodine, Approved December 1997

Evista (raloxifene hydrochloride); Eli Lilly; Treatment for the prevention of osteoporosis, Approved December 1997

Ketoprofen; Schein Pharmaceutical; Generic equivalent or Oruvail, Approved December 1997

Skelid (tiludronate disodium); Sanofi-aventis; Treatment for Paget’s disease of bone, Approved March 1997

Synvisc, Synvisc-One (Hylan GF 20); Genzyme; For the treatment of pain associated with osteoarthritis of the knee, Approved August 1997

Tolmetin Sodium; Teva Pharmaceutical; Treatment for arthritis, Approved March 1997

Drugs Approved in 1996

Kadian; Purepac Pharmaceutical; Treatment for chronic moderate to severe pain, Approved July 1996

Naprelan (naproxen sodium); Elan Pharmaceuticals, Wyeth; Treatment for osteoarthritis and rheumatoid arthritis, Approved January 1996

OxyContin (oxycodone HCl controlled-release); Purdue Pharma; Treatment for pain associated with musculoskeletal conditions, Approved May 1996

Saizen; Ares-Serono; Treatment for growth hormone deficiency and Turner Syndrome, Approved May 1996

Seprafilm; Genzyme; Treatment for the reduction of scar tissue as a result of abdominal or pelvic surgery, Approved August 1996

Zanaflex (tizanidine hydrochloride); Elan Pharmaceuticals; Treatment for muscle spasticity, Approved December 1996

Drugs Approved in 1995

Fosamax (alendronate sodium); Merck; Treatment for osteoporosis in women after menopause and Paget's Disease of Bone, Approved on September 29, 1995

Miacalcin (calcitonin-salmon) Nasal Spray; Sandoz Pharmaceuticals; Treatment for post-menopausal osteoporosis, Approved on August 17, 1995

Prempro & Premphase (conjugated estrogens/medroxyprogesterone acetate tablets); Wyeth; Treatment for postmenopausal hormone replacement, postmenopausal osteoporosis, Approved November 1995