Par Pharmaceutical Companies Inc. (PRX) said the FDA has approved Oravig buccal tablets for the treatment of oropharyngeal candidiasis or OPC, more commonly known as thrush, in adults and children age 16 and older.
Oravig is the first and only local, oral prescription formulation of miconazole - an antifungal medication - approved for this use in the U.S. It is approved in 26 countries and is currently being marketed in several EU territories including France, Germany and the UK under the trade name Loramyc.
Oravig will be offered in 50 mg dosage strength and is expected to be available in retail pharmacies in the third quarter of 2010.
For comments and feedback: editorial@rttnews.com