Pink Sheet is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

PAR OUTGOING PRESIDENT PERRY LEVINE WILL STAY WITH COMPANY UNTIL

Executive Summary

PAR OUTGOING PRESIDENT PERRY LEVINE WILL STAY WITH COMPANY UNTIL a replacement is found. In the wake of Par's Aug. 8 announcement that the cofounder had informed the company of his intention to retire, a spokesperson said Levine would remain to oversee day-to-day operations until a new president comes on board. Levine, 68, is said to be in poor health. The firm's board of directors has appointed a search committee to select a new president. The committee is currently interviewing several executive search firms to help in the selection process. Levine's departure ensures the likelihood of new management for Par. Another founding member of Par, Senior VP and Secretary Ashok Patel, resigned from the company in April after being charged with giving illegal gratuities to FDA generics reviewer Charles Chang. Par Senior VP R. K. Patel, the third founding member of the company, took a leave of absence after it was discovered that he had switched samples of Par's generic version of Mylan/Lederle's Maxzide during an FDA inspection ("The Pink Sheet" July 31, p. 15). Levine's son, Executive VP Jeffrey Levine, and VP-Regulatory Affairs Barry Geller, also took leave of absences in July after having delayed information to FDA about the switch in samples by R. K. Patel. The younger Levine became aware of the switch on July 6, but did not notify FDA until July 21 about the improprieties. Due to Par's recent legal and regulatory difficulties, the company reported a net after tax loss of $ 3.5 mil. for its third fiscal quarter, ended July 31. Par said the loss will be its first since its initial year of operations. "The charges arise from product recalls, from fines related to unlawful gratuity charges against Par and its subsidiary, Quad Pharmaceuticals, and from certain inventory write-offs," the company said. In the last month, Par has recalled six products. Generic Maxzide (triamterene/hydrochlorothiazide), Orphengesic (orphenadrine citrate), and Orphengesic Forte were recalled on July 24. During the week ending Aug. 11, the company recalled specific lots of megestrol acetate (Bristol-Myers' Megace), Par Decon (phenylpropanolamine HCl with phenylephedrine HCl, phenyltoxamine citrate, and chlorpheniramine maleate), and dexachlorpheniramine maleate (Schering's Polaramine) that had failed stability testing. Among other problems, FDA recently withdrew Par's ANDA approval for chlorzoxazone (McNeil's Parafon Forte) citing manufacturing problems. Par said that it has stopped shipment of the skeletal muscle relaxant but has decided not to recall the product. Maintaining that FDA has no authority to rescind the approval, the company said it is in the process of preparing a response to FDA and has for the meantime set aside the idea of bringing suit against the agency.
Advertisement
Advertisement
UsernamePublicRestriction

Register

PS016085

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel