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BARR LABS RECEIVES FIRST GENERIC APPROVAL OF METHOTREXATE TABLETS

Executive Summary

BARR LABS RECEIVES FIRST GENERIC APPROVAL OF METHOTREXATE TABLETS on Oct. 16. The generic drug manufacturer plans to launch its methotrexate 2.5 mg tablets "no later than Oct. 30." The drug will be sold at an average wholesale price of $91.56 for bottles of 36 tablets and an AWP of $269.45 for bottles of 100. Barr will market the tablets for oncologic indications only. Methotrexate is used alone or in combination with other chemotherapeutics in treating breast and other types of cancer, as well as advanced stage non-Hodgkin's lymphomas. Barr's methotrexate is "AB"-rated (therapeutically equivalent to the brandname drug). Barr conducted a bioequivalence study to gain the approval. Warner-Lambert, brandname manufacturer of methotrexate, has exclusivity until Oct. 31, 1991 on the use of its methotrexate tablets for treating severe rheumatoid arthritis. FDA approved Warner-Lambert's supplemental NDA for the new indication in October 1988. Warner-Lambert designed a Rheumatrex Methotrexate Dose Pack for the use of its 2.5 mg tabs for the arthritis indication. Warner-Lambert says its methotrexate tabs are used primarily for rheumatoid arthritis, not for oncological treatment. Barr anticipates gaining "up to 40% of the innovator's market," a same-day release states. The firm estimated 1989 sales of the drug to be over $30 mil. Barr also noted that it is the only generic manufacturer of both methotrexate tabs and an "AB"-rated leucovorin calcium therapy, a chemotherapy-rescue drug. A number of generic firms sell methotrexate in injectable form. Barr's ANDA for methotrexate was mentioned in the firm's April 12 letter to FDA Acting Commissioner Benson that accused the agency of, among other things, retaliating against Barr by purposely delaying the review of its ANDAs and issuing non-approvals ("The Pink Sheet" April 30, p. 5). The letter states that in August 1989, FDA told Barr there was "no problem" with its methotrexate ANDA, and in October informed the company that the application was not approvable. The reason, the letter notes, is "FDA misquoted and then misapplied an FDA regulation to Barr." Another Barr ANDA, erythromycin estolate oral suspension, also cited in the company's letter, was approved two days after methotrexate. The broad spectrum antibiotic is Barr's "first product approval of a liquid dose form," the firm said in a release. Barr pointed out that the approval "will allow the company to commence production in its extensive liquid facility that has been constructed over the past several years in anticipation of FDA approval of the company's liquid applications." Barr has 12 applications for liquid products pending at the agency.
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