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Status:
US Previously Marketed
Source:
UTIBRON by NOVARTIS
(2015)
Source URL:
First approved in 2011
Source:
ARCAPTA NEOHALER by NOVARTIS
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
Indacaterol is an ultra-long-acting beta-adrenoceptor agonist developed by Novartis. It was approved by the European Medicines Agency (EMA) under the trade name Onbrez Breezhaler on November 30, 2009, and by the United States Food and Drug Administration (FDA), under the trade name Arcapta Neohaler, on July 1, 2011. It needs to be taken only once a day, unlike the related drugs formoterol and salmeterol. It is licensed only for the treatment of chronic obstructive pulmonary disease (COPD) (long-term data in patients with asthma are thus far lacking). It is delivered as an aerosol formulation through a dry powder inhaler.
Status:
US Previously Marketed
Source:
INCIVEK by VERTEX PHARMS
(2011)
Source URL:
First approved in 2011
Source:
INCIVEK by VERTEX PHARMS
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Telaprevir (marketed under the brand names Incivek and Incivo) is a direct-acting antiviralagent against the hepatitis C virus (HCV). It is a hepatitis C virus NS3/4A protease inhibitor indicated for the treatment of genotype 1 chronic hepatitis C (CHC) in adult patients with compensated liver disease, including cirrhosis, who are treatment-naïve or who have been previously treated with interferon-based treatment, including prior null responders, partial responders, and relapsers in combination with peginterferon alfa and ribavirin. Telaprevir is not used as a monotherapy. It is necessary for the proteolytic cleavage of the HCV encoded polyprotein into mature forms of the NS4A, NS4B, NS5A and NS5B proteins and essential for viral replication. It belongs to the chemical class of alpha-ketoamids and binds to NS3/4A in a covalent but reversible manner.
Status:
US Previously Marketed
Source:
VICTRELIS by MERCK SHARP DOHME
(2011)
Source URL:
First approved in 2011
Source:
VICTRELIS by MERCK SHARP DOHME
Source URL:
Class (Stereo):
CHEMICAL (MIXED)
Conditions:
Boceprevir (trade name Victrelis) is first-generation, selective, small molecule inhibitor of the non-structural serine protease (NS3) and NS4A polypeptide complex (NS3/NS4A) and is a direct acting antiviral drug against the hepatitis C virus. It is indicated the treatment of chronic hepatitis C (CHC) genotype 1 infection, in combination with peginterferon alfa and ribavirin, in adult patients (18 years of age and older) with compensated liver disease, including cirrhosis, who are previously untreated or who have failed previous interferon and ribavirin therapy. Boceprevir is not approved as a monotherapy. Upon administration, boceprevir reversibly binds to the active center of the HCV NS3/NS4A and prevents NS3/NS4A protease-mediated polyprotein maturation. This disrupts the processing of viral proteins and the formation of a viral replication complex, which inhibits viral replication in HCV genotrype 1-infected host cells. NS3, a serine protease, is essential for the proteolytic cleavages within the HCV polyprotein and plays a key role during HCV viral RNA replication. NS4A is an activating factor for NS3.
Status:
US Previously Marketed
Source:
21 CFR 310.545(a)(24)(i) menstrual/diuretic ethyl nitrate
Source URL:
First approved in 2011
Source:
21 CFR 333A
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Ethyl nitrate is an inhaled organic nitrate that affects pulmonary vascular tone and may be used as a possible treatment for persistent pulmonary hypertension of the newborn. Ethyl nitrate acts by generating NO, which activates soluble guanylate cyclase to increase intracellular cyclic GMP. This, in turn, leads to a decrease in intracellular calcium and relaxation of the vascular smooth muscle.
Status:
US Previously Marketed
Source:
21 CFR 310.545(a)(18)(ii) skin protectant:astringent polyoxeythylene laurate
Source URL:
First approved in 2011
Source:
21 CFR 352
Source URL:
Class (Stereo):
CHEMICAL (RACEMIC)
Propylene glycol 1-laurate is an excipient often used as excipient in transdermal formulations to overcome the formidable barrier offered by the epidermis to achieve the target flux.
Status:
US Previously Marketed
Source:
21 CFR 310.545(a)(10)(v) external analgesic:fever blister/cold sore glycol salicylate
Source URL:
First approved in 2011
Source:
21 CFR 348
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Glycol Salicylate is a nonsteroidal antiinflammatory drug, it is an ingredient of many rubefacient creams and sprays for the relief of aches, pains and stiffness in muscles joints and tendons. It is an analgesic and anti-inflammatory agent, used topically. It is also included in preparations for soothing haemorrhoids. Glycol Salicylate is a component of Salonsip Gel Patch. Salonsip Gel Patch, manufactured by Hisamitsu Pharmaceutical Co., Inc. of Tosu City, Japan, consists of Glycol Salicylate 1.25%, l-menthol 1.00%, Tocopherol Acetate 1.0%, dl-camphor 0.1%.
Status:
US Previously Marketed
Source:
21 CFR 310.502(a) certain drugs 1,1,1-trichloroethane
Source URL:
First approved in 2011
Source:
21 CFR 352
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
1,1,1-trichloroethane (methyl chloroform) is a colorless liquid or vapour with a sharp sweet smell. It dissolves in water and other chemicals and easily evaporates into the air. TCE is non-flammable. Trichloroethane is used as a solvent and degreasing agent in industry. It is an ingredient in consumer products such as household cleaners, glues, and aerosol sprays. Methyl chloroform is also used as a chemical intermediate in the production of vinylidene chloride. It was formerly used as a food and grain fumigant. Excessive absorption of this substance through the lungs or gastrointestinal tract produces central nervous system (CNS) depression proportional to the amount absorbed. Mild liver and kidney dysfunction may occur transiently following recovery from CNS depression. The consumption of trichloroethane has been banned by the 1987 Montreal Protocol because of its ozone-depleting potential.
Status:
Possibly Marketed Outside US
Source:
21 CFR 352
(2015)
Source URL:
First approved in 2011
Source:
M016
Source URL:
Class (Stereo):
CHEMICAL (EPIMERIC)
Status:
Possibly Marketed Outside US
First approved in 2011
Source:
EnLyte by Jaymac Pharma
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Cobamamide is one of the active forms of vitamin B12 that is also known as adenosylcobalamin or dibencozide. This drug is available as a nutritional supplement to prevent the vitamin B12 deficiency. Liposomal formulation of cobamamide was developed for the treatment of atopic dermatitis by a Korean company Hanall Biopharma.
Status:
Possibly Marketed Outside US
Source:
Salicylic Acid by PruGen, Inc.
(2011)
Source URL:
First approved in 2011
Source:
Salicylic Acid by PruGen, Inc.
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)