Pharmaceutical Product Guide » ANDA

Cetirizine receives FDA approval

Kimberly O'Brien — Fri, 31 Jul 2009 04:23:13 +0000

Taro Pharmaceutical Industries Ltd has received approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for cetirizine hydrochloride tablets (OTC). Cetirizine Tablets are approved for the temporary relief of symptoms due to hay fever or other respiratory allergies (sneezing; runny nose; itchy, watery eyes; itchy throat or nose) in adults and children 2 years of age and older. The tablets will be available in 5 mg and 10 mg strengths. The Cetirizine Tablets are bioequivalent to McNeil Consumer Healthcare’s Zyrtec®.

MDRNA Announces Tentative FDA Approval Of Generic Calcitonin-Salmon Nasal Spray

Kimberly O'Brien — Thu, 18 Dec 2008 12:08:04 +0000

MDRNA, Inc. has announced that the U.S. Food and Drug Administration (FDA) has granted tentative approval of MDRNA’s Abbreviated New Drug Application (ANDA) for generic calcitonin-salmon nasal spray for the treatment of osteoporosis. Full FDA approval would follow the completion of Apotex’s 180-day exclusivity period, or June 2009. MDRNA’s generic calcitonin-salmon nasal spray, a legacy product developed by MDRNA in the early 2000s, is the generic equivalent of Miacalcin® marketed by Novartis Pharmaceuticals Corporation. U.S. sales of Miacalcin® were approximately $147 million in 2007.

Sun Pharma gets FDA nod for generic Tessalon

Kimberly O'Brien — Mon, 05 May 2008 18:17:01 +0000

Sun Pharmaceutical Industries has received FDA approval for its Abbreviated New Drug Application (ANDA) for the generic version of Forest Laboratories’ Tessalon (benzonatate) capsule. Tessalon capsules are used in treating cough caused by common cold, pneumonia and other lung infections. According to Sun Pharma, the annual US sales of the brand and generic Tessalon are approximately $40 million.