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 |
