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(Teriflunomide) is used to treat relapsing forms of multiple sclerosis (MS). Aubagio is used to reduce flare-ups in people with relapsing MS. Aubagio is not a cure for MS.
Manufactured by: Genzyme Corporation, a Sanofi Company
Active Ingredient(s): Teriflunomide
Dosage Form: Film coated tablets, oral
Strength: 7 mg and 14 mg
FDA approved: September 12, 2012
More information about Aubagio:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202992s000lbl.pdf
is indicated for the treatment of HIV-1 infection in:
(1) patients 12 years of age and older with no antiretroviral treatment history and with HIV-1 RNA less than or equal to 100,000 copies/mL at the start of therapy, and
(2) in certain virologically suppressed (HIV-1 RNA < 50 copies/ml) patients.
Manufactured by: Gilead Sciences. Inc
Active Ingredient(s): Emtricitabine, Rilpivirine Hydrochloride, and Tenofovir Disoproxil Fumarate.
Dosage Form: Tablets, Oral
Strength: Each tablet contains 200 mg of Emtricitabine (FTC), 27.5 mg of Rilpivirine hydrochloride (equivalent to 25 mg of Rilpivirine) and 300 mg of Tenofovir disoproxil fumarate (Tenofovir DF or TDF, equivalent to 245 mg of Tenofovir disoproxil).
FDA approved: December 13, 2013
More information about Complera:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202123s000lbl.pdf
www.gilead.com/~/media/files/pdfs/medicines/hiv/complera/complera_pi_old.pdf
is indicated for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older. Descovy is a two-drug combination of Emtricitabine (FTC) and Tenofovir Alafenamide (TAF).
Manufactured by: Gilead Sciences, Inc.
Active Ingredient(s): Emtricitabine and Tenofovir Alafenamide
Dosage Form: Film coated Tablets, Oral
Strength: Each tablet contains 200 mg of Emtricitabine and 25 mg Tenofovir Alafenamide.
FDA approved: April 4, 2016
More information about Descovy:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208215s000lbl.pdf
http://www.gilead.com/~/media/files/pdfs/medicines/hiv/descovy/descovy_pi.pdf?la=en
is a corticosteroid indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 5 years of age and older.
Manufactured by: Marathon Pharmaceuticals, LLC and marketed by PTC Therapeutics
Active Ingredient(s): Deflazacort
Dosage Form: Tablet, oral
Strength: 6 mg, 18 mg, 30 mg, and 36 mg
FDA approved: February 9, 2017
More information about Emflaza:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208684s000,208685s000lbl.pdf
is indicated for the treatment of adult patients with chronic HCV genotype 1, 2, 3, 4, 5 or 6 infection 1) without cirrhosis or with compensated cirrhosis and 2) with decompensated cirrhosis for use in combination with ribavirin.
Manufactured by: Gilead Sciences.Inc
Active Ingredient(s): Sofosbuvir and Velpatasvir
Dosage Form: Tablet, oral
Strength: Each Epclusa tablet contains 400 mg of Sofosbuvir and 100 mg of Velpatasvir.
FDA approved: June 28, 2016
More information about Epclusa:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208341s000lbl.pdf
http://www.gilead.com/~/media/Files/pdfs/medicines/liver-disease/epclusa/epclusa_pi.pdf
is a pyridone indicated for the treatment of idiopathic pulmonary fibrosis (IPF).
Manufactured by: Roche-Genentech, Inc.
Active Ingredient(s): Pirfenidone
Dosage Form: Capsules, Oral
Strength: 267 mg
FDA approved: October 15, 2014
More information about Esbriet:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022535s000lbl.pdf
is indicated for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older who have no antiretroviral treatment history. It can also replace the current antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen for at least 6 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of Genvoya.
Manufactured by: Gilead Sciences, Inc
Active Ingredient(s): Cobicistat; Elvitegravir; Emtricitabine; Tenofoviralafenamide fumarate
Dosage Form: Tablet, oral
Strength: 150 mg of Elvitegravir, 150 mg of Cobicistat, 200 mg of Emtricitabine, and 10 mg of Tenofovir Alafenamide Fumarate.
FDA approved: November 5, 2015
More information about Genvoya:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207561s000lbl.pdf
www.gilead.com/~/media/files/pdfs/medicines/hiv/genvoya/genvoya_pi.pdf
is indicated for the treatment of chronic hepatitis C (CHC) genotype 1 infection in adults. Harvoni is a fixed-dose combination of Ledipasvir, a hepatitis C virus (HCV) NS5A inhibitor, and Sofosbuvir, an HCV nucleotide analog NS5B polymerase inhibitor.
Manufactured by: Gilead Sciences.Inc.
Active Ingredient(s): Ledipasvir; Sofosbuvir
Dosage Form: Tablet, oral
Strength: 90 mg; 400 mg
FDA approved: October 10, 2014
More information about Harvoni:
http://www.gilead.com/~/media/Files/pdfs/medicines/liver-disease/harvoni/harvoni_pi.pdf
is indicated for the treatment of patients with advanced renal cell carcinoma.
Manufactured by: Bayer Healthcare
Active Ingredient(s): Sorafenib Tosylate
Dosage Form: Film coated tablets, oral
Strength: Each tablet contains Sorafenib Tosylate (274 mg) equivalent to 200 mg of Sorafenib
FDA approved: December 1, 2005
More information about Nexavar:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021923s015lbl.pdf
is indicated for the treatment of HIV-1 infection in patients 12 years of age and older as initial therapy in those with no antiretroviral treatment history with HIV-1 RNA less than or equal to 100,000 copies per mL. Odefsey can also replace a stable antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) for at least six months with no history of treatment failure and no known substitutions associated with resistance to the individual components of Odefsey.
Manufactured by: Gilead Sciences, Inc
Active Ingredient(s): Emtricitabine; Rilpivirine Hydrochloride; Tenofoviral Afenamide Fumarate
Dosage Form: Film Tablet, oral
Strength: Each tablet contains 200 mg of Emtricitabine (FTC), 25 mg of RPV (equivalent to 27.5 of Rilpivirine Hydrochloride) and 25 mg of Tenofovir (equivalent to 28 mg of Tenofovir Alafenamide Fumarate)
FDA approved: March 1, 2016
More information about Odefsey:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208351s000lbl.pdf
https://www.gilead.com/~/media/files/pdfs/medicines/hiv/odefsey/odefsey_pi.pdf?la=en
is indicated for the treatment of idiopathic pulmonary fibrosis.
Manufactured by: Boehringer Ingelheim
Active Ingredient(s): Nintedanib Esylate Ethanesulfonate,
Dosage Form: Capsule, oral
Strength: 100 mg, 150 mg
FDA approved: October 15, 2014
More information about Ofey:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205832s000lbl.pdf
http://docs.boehringer-ingelheim.com/Prescribing%20Information/PIs/Ofev/ofev.pdf
is indicated for patients with multiple myeloma who have received at least two prior therapies including Lenalidomide and Bortezomib and have demonstrated disease progression on or within 60 days of completion of the last therapy.
Manufactured by: Celgene Corp
Active Ingredient(s): Pomalidomide
Dosage Form: Capsule, oral
Strength: 1 mg, 2 mg, 3 mg and 4 mg
FDA approved: February 8, 2013
More information about Pomalyst:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204026lbl.pdf
is indicated for the treatment of:
1) Refractory complex partial seizures as adjunctive therapy in patients ≥10 years of age who have responded inadequately to several alternative treatments
2) Infantile spasms–monotherapy in infants 1 month to 2 years of age for whom the potential benefits outweigh the potential risk of vision loss.
Manufactured by: Lundbeck Pharms, LLC
Active Ingredient(s): Vigabatrin
Dosage Form: Solution, oral
Strength: 500 mg/packet
FDA approved: August 21, 2009
More information about Sabril:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020427s016,022006s018lbl.pdf
https://www.lundbeck.com/upload/us/files/pdf/Products/Sabril_PI_US_EN.pdf
is indicated for the treatment of patients with Wilson’s disease who are intolerant of Penicillamine.
Manufactured by: Valeant Pharmaceuticals North America, LLC
Active Ingredient(s): Trientine Hydrochloride
Dosage Form: Capsule, oral
Strength: 250 mg
FDA approved: November 8, 1985
More information about Syprine:
is indicatedfor the treatment of renal cell carcinoma (RCC) and Imatinib-resistant gastrointestinal stromal tumor.
Manufactured by: Pfizer, Inc.
Active Ingredient(s): Sunitinib Malate
Dosage Form: Capsules, oral
Strength: 12.5 mg, 50 mg
FDA approved: May 20, 2011(First approval26th January, 2006)
More information about Sutent:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021968lbl.pdf
is indicated for the treatment of chronic hepatitis C (CHC) infection as a component of a combination antiviral treatment regimen. Sovaldi efficacy has been established in subjects with HCV genotype 1, 2, 3 or 4 infection, including those with hepatocellular carcinoma meeting Milan criteria (awaiting liver transplantation) and those with HCV/HIV-1 co-infection.
Manufactured by: Gilead Sciences, Inc
Active Ingredient(s): Sofosbuvir
Dosage Form: Tablet, oral
Strength: 400 mg
FDA approved: December 6, 2013
More information about Sovaldi:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204671s000lbl.pdf
http://www.gilead.com/~/media/Files/pdfs/medicines/liver-disease/sovaldi/sovaldi_pi.pdf
is a treatment indicated for:
1) First-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test.
2) Maintenance treatment of patients with locally advanced or metastatic NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy.
3) Treatment of locally advanced or metastatic NSCLC after failure of at least one prior chemotherapy regimen.
4) First-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer, in combination with gemcitabine.
Manufactured by: Genentech
Active Ingredient(s): Erlotinib Hydrochloride
Dosage Form: Tablet, oral
Strength: 25 mg, 100 mg, 150 mg
FDA approved: November 18, 2004
More information about Tarceva:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021743s026lbl.pdf
is indicated for the treatment of chronic phase and accelerated phase Philadelphia chromosome positive chronic myelogenous leukemia (CML) in adult patients resistant to or intolerant to prior therapy that included Imatinib.
Manufactured by: Novartis
Active Ingredient(s): Nilotinib Hydrochloride Monohydrate
Dosage Form: Capsule, oral
Strength: 150 mg, 200 mg
FDA approved: October 29, 2007
More information about Tasigna:
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&applno=022068
(Ambrisentan) is indicated for treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III, including use in combination treatment.
Manufactured by: Gilead Sciences, Inc.
Active Ingredient(s): Ambrisentan
Dosage Form: Tablet, oral
Strength: 5 mg
FDA approved: It is registered as Letairis in the US; FDA approval June 15, 2007
More information about Volibris:
is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. It may be used as monotherapy or in combination with methotrexate or other non-biologic disease-modifying antirheumatic drugs (DMARDs).
Manufactured by: Pfizer, Inc
Active Ingredient(s): Tofacitinib Citrate
Dosage Form: Tablet, oral
Strength: 5 mg
FDA approved: November 6, 2012
More information about Xeljanz
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203214s000lbl.pdf
is indicated for the treatment of adult patients with active psoriatic arthritis and in patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.
Manufactured by: Celgene Corp
Active Ingredient(s): Apremilast
Dosage Form: Tablet, oral
Strength: 10 mg, 20 mg and 30 mg
FDA approved: March 21, 2014
More information about Otezla:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205437s000lbl.pdf
(Ambrisentan) is indicated for the treatment of pulmonary arterial hypertension (WHO Group 1) in patients with WHO class II or III symptoms. Letairis is intended to improve exercise capacity and delay clinical worsening.
Manufactured by: Gilead Sciences.Inc
Active Ingredient(s): Ambrisentan
Dosage Form: Tablet, oral
Strength: 5 mg, 10 mg
FDA approved: June 15, 2007
More information on Letairis:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022081s000_LBL.pdf
www.gilead.com/~/media/files/pdfs/medicines/cardiovascular/letairis/letairis_pi.pdf