INTERPHARM RECALLING THREE STRENGTHS OF GENERIC CLONIDINE
INTERPHARM RECALLING THREE STRENGTHS OF GENERIC CLONIDINE after FDA discovered that samples submitted by the Plainview, NY-based generic firm for bioequivalence testing differed from the marketed product. The recall, announced by the agency June 27, is to the pharmacy level and involves the 0.1, 0.2, and 0.3 mg strengths of the antihypertensive drug, a generic version of Boehringer Ingelheim's Catapres. The clonidine recall has been triggered by FDA's finding that tablets submitted to the contract lab Pharmakinetics for bioequivalence testing prior to the October, 1986 approval of Interpharm's ANDA for the drug are not the same in appearance as the tablets described in the ANDA and currently marketed. The discrepancy was discovered during FDA's review of 1,500 drug samples from 20 top generic firms begun last year in the midst of the generic drug scandal. Interpharm has also agreed to an audit of its 23 other product approvals, FDA says. An FDA statement on the recall explains that an examination by the FDA laboratory in St. Louis "revealed that samples of clonidine hydrochloride 0.3 mg tablets submitted for bioequivalence testing by Interpharm were not the same as the product on the market. The tablets subjected to bioequivalence tests prior to approval were peach-colored whereas the tablets Interpharm is marketing are blue. An examination of Interpharm's manufacturing and production data turned up no record of the firm's having made a peach-colored batch." In addition, FDA notes, in its ANDA for clonidine, Interpharm provided manufacturing and testing records of blue tablets that included blue tablets identified with the same batch number as that found on containers of the peach-colored tablets. Boehringer Ingelheim's 0.3 mg Catapres tablets are peach-colored, according to their description in the Physician's Desk Reference. However, the peach-colored samples taken from Interpharm's biotest reportedly may have been produced by another generic drug manufacturer. FDA said it "has no evidence that there is a safety problem with Interpharm's product." However, the agency questioned "whether the Interpharm product is therapeutically equivalent to the brandname product." FDA recommended that patients who use the product consult their doctor or pharmacist about the "advisability of another product." Other firms that hold ANDAs for clonidine, which has been off patent since 1985, include Danbury, Duramed, American Therapeutics, Geneva, Biocraft, Par and Warner-Lambert. Interpharm will begin contacting distributors by phone June 28 and is working with FDA on letters to distributors and pharmacists expected to go out by July 2. Interpharm is the third firm to come to woe during FDA's inspection of the top 20 generic drug manufacturers. The agency also discovered discrepancies in ANDAs submitted by Quantum and Chelsea. Generic clonidine and Interpharm were cited previously this year in a report by the HHS Inspector General that was critical of FDA's Office of Generic Drugs. The report said the division's managers failed to notice wide discrepancies in approval times for different ANDAs for the same drugs. The ANDA for Interpharm's clonidine was approved in a record 159 days, while a clonindine approval for rival generic firm Mylan took 925 days, the report said. The latest evidence of generic industry troubles was not overlooked in Washington. In a joint statement issued June 27, Reps. Dingell (D-Mich.) and Bliley (R-Va.) said they were "appalled, but no longer surprised, by wrongdoing [of] additional generic manufacturers." The congressmen predicted that Interpharm "undoubtedly" be added to "the list of seven or more companies being investigated by the U.S. Attorney in Baltimore for fraud and false statements." Principal cosponsors of HR 4810 -- an "emergency" bill to boost FDA regulatory and enforcement powers over the generic drug industry -- Dingell and Bliley said the disclosures involving Interpharm "underscore the need for the tough medicine contained in the bipartisan legislation we have introduced to preserve the streamlined generic drug approval process and Americans' access to lower-cost medicines." The legislators urged "honest firms in the industry currently sitting on the sidelines [to] join with the 39 members of the Energy and Commerce Committee who cosponsored HR 4810 and with the reform-minded generic drug manufacturers who are supporting the legislation."
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