Taro Pharmaceutical Industries Ltd. has received approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Meloxicam tablets, 7.5 mg and 15 mg.
Taro's meloxicam tablets are used for the relief of the signs and symptoms of osteoarthritis and rheumatoid arthritis. This new Taro prescription product is bioequivalent to Boehringer Ingelheim's Mobic tablets. According to industry sources, branded and generic meloxicam tablet products had US sales of approximately $105 million in the third quarter of 2006.
Taro it has received tentative approval from the FDA for its Abbreviated New Drug Application ("ANDA") for Cetirizine Hydrochloride Syrup, 1 mg/mL ("cetirizine syrup").
The FDA has determined that Taro's cetirizine syrup is safe and effective for use when compared with the reference listed drug product, Zyrtec syrup of Pfizer, Inc. Zyrtec Syrup is a prescription product used for treating allergic rhinitis and chronic urticaria (hives). The tentative ANDA approval for Taro's cetirizine syrup is an FDA determination that Taro's ANDA submission for this product currently satisfies the substantive requirements for approval, subject to the expiration of all relevant patents or statutorily imposed exclusivities and restrictions, or any new information that may come to the FDA's attention. Tentative approvals do not grant marketing rights; a company may only market a product upon receiving final approval for an ANDA submission. According to industry sources, annual US sales of Zyrtec syrup are approximately $153 million. It is expected that, upon the December 2007 expiration of the paediatric exclusivity covering Zyrtec Syrup, as allowed under applicable law, there will be additional generic competition for Zyrtec.