Chain Drug Review - More ANDAs are approved by the FDA
WASHINGTON — Several generic pharmaceutical firms have had abbreviated new drug applications (ANDA) approved by the Food and Drug Administration.
Able Laboratories Inc. and Lannett Co., for example, are among those receiving agency clearance for methocarbamol tablets, USP 500 mg and 700 mg. The product is equivalent to Robaxin, marketed by Wyeth Pharmaceuticals, and is used to relieve discomfort associated with acute, painful musculoskeletal conditions. Industry estimates for methocarbamol tablets peg the market at $65 million.
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Barr Laboratories Inc.’s ANDA for generic Adderall tablets, 7.5, 12.5 and 15 mg, have been approved along with 180 days of exclusivity for the three strengths. The product, indicated as part of a treatment program for children suffering educational, psychological and social disorders, is AB-rated to Shire Inc.’s Adderall. In February 2002 the company was the first to launch the product in 5, 10, 20 and 30 mg.
“Our ability to gain the first generic approval and 180-day market exclusivity for the additional strengths of generic Adderall expands our current portfolio of dextroamphetamine products and demonstrates our ability to accelerate development of barrier-to-entry products to ensure that we reach the marketplace before competitors,” declares Bruce Downey, chairman and chief executive officer.
Mylan Laboratories Inc. will manufacture its recently approved tizanidine hydrochloride tablets, 2 mg and 4mg, at its Morgantown, W.Va., production plant. The product is the generic version of Elan Corp.’s Zanaflex, a short-acting drug indicated for the management of spasticity.
Ranbaxy Laboratories received FDA approval for its generic version of 3M Pharmaceuticals’ Tambocor.
Its ANDA for flecainide acetate tablets in 50,100 and 150 mg will compete in a market that the company said achieved $105.6 million in sales last year. Ranbaxy’s Ohm Laboratories unit will make the drug, which is used to prevent irregular heartbeat.
Barr received approval for its generic version in October, and the Par Pharmaceutical unit of Pharmaceutical Resources Inc. began shipping its flecainide acetate tablets last June under a license from 3M.
Ranbaxy also was granted recent clearance to market amoxicillin and clavulanate potassium for oral suspension USP. It has been rated therapeutically equivalent to Glaxo-SmithKline’s Augmentin, a treatment for infections.
Teva Pharmaceuticals Industries Ltd. has received tentative approval of metformin HCI extended-release tablets. Glucophage XR, Bristol-Myers Squibb Co.’s name for the diabetes product, has annual sales of about $410 million.
Watson Pharmaceuticals Inc. has launched Microgestin, a generic version of Pfizer Inc.’s Loestrin. Watson’s oral contraceptive is debuting in 1 mg/20 mcg and 1.5 mg/30 mcg. strengths.
“The launch of Microgestin, paired with our previously launched Microgestin FE, completes our full line of oral contraceptives,” president and chief operating officer Joe Pupa says.
“This further supplements our extensive oral contraceptive product portfolio consisting of 14 families and 22 different product strengths.”
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