March 2010 Approvals

Product	Sponsor	Indication	Date Approved (Application No.)
New Drug
Asclera Polidocanol 1S	Chemische Fabirk Kreussler	Injectable sclerosing agent for treatment of uncomplicated spider veins (varicose veins less than 1 mm in diameter) and uncomplicated reticular veins (varicose veins 1 to 3 mm in diameter) in the lower extremity	3/30/2010 (21-201)
Carbaglu Carglumic acid 1P	R&R Registrations	Carbamoyl phosphate synthetase 1 activator approved as adjunctive therapy for treatment of acute hyperammonemia due to deficiency of the hepatic enzyme N-acetylglutamate synthase (NAGS) and as maintenance therapy for NAGS deficiency	3/18/2010 (22-562)
Differin Adapalene 3S	Galderma	Lotion formulation (1%) of the retinoid adapalene for topical treatment of acne vulgaris in patients 12 years and older	3/17/2010 (22-502)
Exalgo Hydromorphone 3P	Alza	Extended-release opioid analgesic formulated for once-daily use with Alza's OROS Push-Pull osmotic delivery system, for management of moderate to severe pain in opioid-tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period of time	3/1/2010 (21-217)
Indomethacin 5S	APP	Cardiovascular drug formulated for injection approved under the 505(b)(2) NDA pathway to close a hemodynamically significant patent ductus arteriosus in premature infants weighing between 500 and 1,750 g	3/17/2010 (22-536)
Mirapex ER Pramipexole 3S	Boehringer Ingelheim	Extended-release formulation of the non-ergot dopamine agonist for treatment of the signs and symptoms of advanced idiopathic Parkinson's disease	3/19/2010 (22-514)
Silenor Doxepin 3S	Somaxon	Low-dose formulation of the antidepressant approved under the 505(b)(2) NDA pathway for treatment of insomnia characterized by difficulties with sleep maintenance	3/17/2010 (22-036)
Trelstar Triptorelin 3S	Watson	Injectable gonadatropin releasing hormone agonist for the palliative treatment of advanced prostate cancer	3/10/2010 (22-437)
Xifaxan Rifaximin 6P	Salix	Rifamycin antibacterial indicated for reduction in risk of overt hepatic encephalopathy recurrence in patients 18 years of age and older; new use for the drug, which is approved for treatment of traveler's diarrhea	3/24/2010 (22-483)
Zyclara Imiquimod 5S	Graceway	Topical immune-response modifying cream (3.5%) formulated for daily use on a 6-week dosing cycle (two weeks on and two weeks off) to treat actinic keratosis of the face and/or scalp	3/25/2010 (22-483)
P: Priority Review (drug represents therapeutic gain over existing therapies) S: Standard review V: Orphan Drug 1: New molecular entity 2: New Salt 3: New formulation 4: New combination 5: Already marketed in U.S. by another firm 6: Already marketed by same firm, usually a new indication 7: First NDA for already marketed drug