| Class | Name/Company | Approval Dates and Comments |
Pediculocides | Pyrethrins/Piperonyl butoxide | The US FDA approved this mousse formulation in July 1999 for the treatment of head lice. |
Atopic Dermatitis Agent | Fluocinolone acetonide 0.01% | The US FDA approved this topical oil in October 1999 for the additional indication of treating moderate to severe stable atopic dermatitis in patients ≥ 6 years of age. |
Antibiotic Agents | Quinupristin/ Dalfopristin | The US FDA granted accelerated approval in September 1999 for this antibacterial drug for the treatment of infections associated with vancomycin-resistant Enterococcus faecium bacteremia (VREF) and skin-structure infections (SSSI) caused by methicillinsusceptible Staphylococcus aureus or Streptococcus pyogenes. Synercid is the first drug in the streptogramin class approved for human use in the US. |
| Drug News | ||
Wound Care | In September 1999 Regranex Gel (becaplermin 0.01% gel) (Ortho-McNeil) was launched in the UK for the treatment of diabetic ulcers. It is the first product to have a marketing authorization in Europe for this indication. It is available in the US and Canada. | |
Antipruritic Agents | The British Journal of Dermatology (140(5):979-980,1999) reported that cetirizine, used in the treatment of allergic disorders such as allergic rhinitis and chronic urticaria, can itself cause maculopapular eruptions and generalized chronic urticaria in rare cases. | |
Leprosy | The World Health Organization (WHO) states that leprosy is nearing elimination worldwide as a public health problem. The use of multidrug therapy (MDT) since 1985 has already reduced the global prevalence of the disease by 85%. The number of countries above the target level has dropped from 122 to 28. However, by the end of 2000, there may still be about 10 countries whose leprosy burden is greater than WHO’s target level of less than one case per 10,000. | |
Antihistamine Agents | Janssen announced its decision to voluntarily discontinue manufacturing, distributing and marketing Hismanal (astemizole) tablets. Hismanal is an antihistamine indicated for relief of symptoms associated with seasonal allergic rhinitis and chronic idiopathic urticaria. It has been available since 1988. | |
Pediculocides | Rid Lice Egg Loosener Gel | In June 1999 Pfizer introduced a new approach to loosen nits from the hair shaft. It is to be used after the shampoo to dissolve the substance that glues the nit to the hair shaft. |
Immunosuppressant | Tacrolimus | A US NDA was filed in September 1999 for this ointment for the treatment of atopic dermatitis. This drug has been approved for marketing in Japan, but has not yet been launched. |
Antiviral Agents | Docosanol | In July 1999 the US FDA asked for more data before it would approve the NDA for this topical cream for oral-facial herpes. |
