|Class||Name/Company||Approval Dates and Comments|
The US FDA approved Targretin capsules in February 2000, to be taken orally once/day, for the treatment of all stages of cutaneous Tcell lymphoma (CTCL) in patients who are refractory to > 1 prior systemic therapy. In November 1999, Ligand submitted a marketing application to the European Union (EU) seeking marketing clearance for treatment of CTCL.
Schering-Plough has withdrawn its EU marketing application for this oncologic agent for the treatment of advanced malignant melanoma (an additional indication). The EU authorities said that additional studies will be needed for approval. It is already approved in the US and Europe for anaplastic astrocytoma.
The US FDA approved this drug in December 1999, for the treatment of solar lentigines.
Pharmacia & Upjohn
A US FDA advisory committee in March 2000, recommended approval of linezolid injection, tablets, and oral suspension for skin and skin structure infections, hospital-acquired pneumonia, and for infections caused by vancomycin-resistant Enterococcus.
HPB – Ottawa approved this antifungal agent in March 2000, for the treatment of systemic or disseminated infections due to Candida, Apergillus or Cryptococcus in patients who are refractory to or intolerant of conventional amphotericin B therapy, or suffer renal impairment.
The US FDA has approved the switch of this drug from prescription to OTC status. Lamisil is the only OTC antifungal liquid indicated for the treatment of interdigital athlete’s foot, jock itch and ringworm.
Phase III trials for Ligand’s alitretinoin 1% gel (Panretin) for the topical treatment of cutaneous lesions in patients with AIDS-related Kaposi’s sarcoma were reported in December 1999. Ligand reported that 35% of patients treated in this 12-week multicenter, vehicle controlled study had at least 50% improvement in their cutaneous lesions.
The labelling for Sporanox (Itraconazole) was changed in March 2000, to indicate this drug’s inhibition of the CYP 3A4 isoenzyme. Serious cardiovascular events have occurred in patients using astemizole, cisapride, pimozide or quinidine concomitantly with CYP 3A4 inhibitors.
SkyePharma PLC signed an agreement with Bioglan Pharma PLC in March 2000, for the manufacture and European marketing and distribution rights to Solarase, a topical gel for actinic keratosis.
Patients should be cautioned about taking herbal products along with pharmaceuticals. Mixing them can lead to side-effects which include bleeding, increased psychiatric effects and hypertension. For example, patients who have clotting disorders or are awaiting surgery should avoid gingko, danshen, dongquai, papaya, or garlic. Phenelzine users should avoid ginseng and those on tricyclic antidepressants should avoid yohimbine. Patients taking cyclosporin, serotonin reuptake inhibitors, or digoxin should avoid St. John’s Wort. St. John’s Wort has also been reported to compromise the effectiveness of the HIV drug indinavir.