Valganciclovir
Valcyte®
Hoffmann-LaRoche
| Drug Class | Generic/Trade/Company Names | Indiction | Approving Regulatory Agency |
Anti-acne Agents | Azelaic Acid | For the topical treatment of mild-to-moderate inflammatory acne. | US FDA |
Clindamycin 1%, Benzoyl Peroxide 5% | Labeling change: the product can now be stored at room temperature for up to 2 months after at room temperature for up to 2 months after | US FDA | |
US FDA | Additional indication: for the treatment of moderate acne in women over 15 years of age. | US FDA | |
Tazarotene | For the treatment of acne vulgaris. | US FDA | |
Tretinoin Gel | For the treatment of acne vulgaris. | TPP – Canada | |
Antibacterial Agents | Cefuroxime, Dextrose for Injection | For the treatment of skin and skin structure infections, lower respiratory tract infections,urinary tract infections, lower respiratory tract infections,urinary tract infections, | US FDA |
Ciprofloxacin | ANDA tentatively approved for this generic form of Bayer’s Cipro® for the treatment of urinary tract, skin and other infections. | US FDA | |
Moxifloxacin HCl | Additional indication: as a once daily treatment for uncomplicated skin and skin structure infections due to Staphylococcus aureus and Streptococcus pyogenes. | US FDA | |
Antifungal Agents | Caspofungin Acetate | For the treatment of invasive aspergillosis in patients who do not respond to, or cannot tolerate other antifungal therapies. | US FDA |
Butenafine HCl | Switched to OTC for the topical treatment of symptomatic inflammatorytinea pedis, tinea cruris and tinea corporis due to Epidermophyton rubrum. | US FDA | |
Butenafine HCl | Additional indication: for the treatment of tinea (pityriasis) versicolor caused by Malassezia furfur, previously known as Pityrosporum orbiculare. | US FDA | |
Clotrimazole, Betamethasone Dipropionate Cream | For the treatment of a variety of fungal conditions. It is bioequivalent to Schering-Plough’s Lotrisone® cream. | US FDA | |
Antihistamine | Desloratidine | To be given once daily for the symptoms of chronic idiopathic urticaria in adults and children >12 years of age. | European Commission of the European Union |
Levocetirizine | For the treatment of seasonal allergic rhinitis, perennial allergic rhinitis, and chronic idiopathic urticaria | German Regulatory Authorities | |
Antimetabolite Agents | Methotrexate | For the treatment of neoplastic disease, psoriasis and rheumatoid arthritis. Trexall® represents new dosage strengths in 5, 7.5, 10, and 15mg tablets. | US FDA |
Antipsoriatic Agents | Calcipotriol, Betamethasone Dipropionate | For the treatment of psoriasis | TPP – Canada |
Antiviral Agents | Varicella Zoster Immune Globulin | This product is a highly purified and specialized antibody against the varicella zoster virus that causes chicken pox. | TPP – Canada |
Valacyclovir HCl | A shorter course of therapy: the new 500mg. caplets can be prescribed as a 3-day course administered twice daily. | US FDA | |
Atopic Dermatitis | Pimecrolimus | For the treatment of mild-to-moderate atopic dermatitis in patients >2 years of age. | US FDA |
Depigmenting Agents | Xtrac™ Excimer Laser System | For the treatment of psoriasis and vitiligo. | US FDA |
Enzyme Replacement Therapy | Recombinant Human Iduronidase (IDUA) | Granted Orphan Drug Status for the proprietary treatment of mucopolysaccharidosis I. | US FDA |
Agalsidase Alfa | For long-term treatment in patients with Fabry’s disease. | Norwegian Medicines Agency NZ’s Reg. Authority Iceland’s Regulatory Authority | |
Agalsidase Beta | For the long-term enzyme replacement therapy in patients with a confirmed diagnosis of Fabry’s disease. | European Commission of the European Union | |
Hair Growth | Eflornithine HCl | For the reduction of unwanted facial hair in women. | US FDA |
TPP – Canada | Amprenavir | Conditional Notice of Compliance: to be used with other antiretroviral agents for the treatment of HIV-1 infection. | TPP – Canada |
HIV Drug Resistance Test | This test can identify which HIV medications have become ineffective because of the virus’ mutation in individual patients. | US FDA | |
Tenofovir Disoproxil Fumerate | For the treatment of HIV infection when taken in combination with other antiretroviral agents | US FDA | |
For the treatment of cytomegalovirus (CMV) retinitis in AIDS patients | US FDA | ||
Hormonal Preparation | Transdermal 17-Beta Estradiol | For the treatment of menopausal symptoms and for the prevention of postmenopausal osteoporosis. | Netherlands’ Regulatory Authority |
Human Skin Construct | Biologically Active Dressing | For patients undergoing hand reconstruction to treat recessive dystrophic epidermolysis bullosa, a rare genetic disorder. | US FDA |
Monoclonal Antibody | Infliximab | For the treatment of severe, active and fistulizing Crohn’s Disease in adult patients who have not responded to conventional treatment | TPP – Canada |
Mouth and Throat Product | Amlexanox | For the treatment of aphthous ulcers. | UK MCA |
Neurotoxins | Botulinum Toxin Type A | Additional indication: for the treatment of glabellar lines associated with corrugator and/or procerus muscle activity. | TPP – Canada |
Oncologic Agents | Arsenic Trioxide | Orphan drug designation given for the treatment of multiple myeloma and myelodysplastic syndromes. | European Commission of the European Union |
Oral Contraceptive | Drospirenone/Ethinyl Estradiol | Contains the progestin drospirenone, which exhibits antimineralocorticoid activity and influences water and electrolyte balance. Reduces sebum output. | US FDA |
Photodynamic Therapy | Aminolevulinic Acid HCl | For the treatment of Actinic Keratosis of the face and scalp. | TPP – Canada |
Sunscreens | Mequinol 2%, Tretinoin 0.01% | For the treatment of solar lentigines and related hyperpigmented lesions. | TPP – Canada |
