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

WARNER-LAMBERT NITROSTAT ACCELERATED RESUPPLY EFFORT

Executive Summary

WARNER-LAMBERT NITROSTAT ACCELERATED RESUPPLY EFFORT is designed to get two-month supplies of bottles of .3 and .4 mg strengths of the Parke-Davis sublingual nitroglycerin product to distributors immediately. Those shipments "should take care of any backlogs and provide an adequate supply of the drug throughout the country by Tuesday Jan. 12," FDA said in a Jan. 8 press release. The agency stepped in to ask the company to expedite shipments of Nitrostat when it became apparent that some pharmacies were experiencing shortages of the widely used acute angina therapy. In the Jan. 8 statement, FDA Commissioner Kessler said: "Today we asked the company to fill the pipeline immediately." At the agency's request, "the company is immediately shipping five lots, that is 300,000 bottles." Manufacture of the .6 mg Nitrostat strength will not begin until late January and the .15 mg strength is being discontinued. Warner-Lambert said in a Jan. 8 letter to pharmacists and doctors that it "will continue to manufacture Nitrostat .3 mg, .4 mg and .6 mg as fast as possible and anticipate[s] a complete resolution of the back-order situation in the next several weeks." Warner-Lambert fell behind in its back-orders of Nitrostat due to a cessation of production at its Puerto Rico facilities from late October to mid-November. W-L had been switching its Nitrostat production from an old machine when problems in procuring parts for the old machine arose and production had to halt, the company says. Nitrostat production was resumed shortly after Thanksgiving; however, by mid-December pharmacies in certain areas of the country were reporting severe shortages. The Nitrostat shortages are unrelated to compliance problems at W-L's Puerto Rico facilities, the company maintains. The halt in production occurred, however, during a period when FDA was conducting its fifth inspection of the facilities in 1992 ("The Pink Sheet" Dec. 14, 1992, p. 12). In a Nov. 24 response to FDA's inspectional observations, the company said it had conducted "an in-depth process investigation" for Nitrostat tablets. Warner-Lambert informed pharmacy groups in December that it was having a "back-order problem" with Nitrostat, without giving details about the source of the problem, and said it would issue an advisory immediately to pharmacies that there may be shortages of the product. However, the company did not send follow-up communications until Jan. 7 when it began sending letters to physicians and pharmacists. The firm followed with a Jan. 8 mailing of a revised letter to 160,000 physicians and 65,000 pharmacies. While there are other nitroglycerin and anti-anginal products on the market, Nitrostat sublingual is the only fast-acting nitroglycerin formulation that is relatively inexpensive. When the shortages began, Warner-Lambert recommended that pharmacists switch patients to Rhone-Poulenc Rorer's Nitrolingual spray or Wyeth-Ayerst's Isordil sublingual. However, pharmacists did not find the alternatives acceptable because RPR's sublingual spray costs almost twice as much per dose and Isordil requires twice the time to take effect. In a separate action, Warner-Lambert is recalling eight pharmaceutical products for manufacturing deficiencies. The company "will be voluntarily recalling certain pharmaceutical products from direct accounts until such time as its manufacturing processes have been revalidated in accordance with FDA standards." Revalidation for the products -- Centrax (prazepam), ergotamine, Estrovis (quinestrol), norethindrone/ethinyl estradiol, norethindrones, phenazopyridine and Tedral (theophylline/ephedrine) -- could take from several weeks to several months, the firm estimated. FDA inspectional reports disclose that a number of the recalled products, as well as Nitrostat, had failed stability testing or had not undergone revalidation following manufacturing process changes.
Advertisement
Advertisement
UsernamePublicRestriction

Register

PS022009

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