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FDA issues draft guidance, seeks comment on identifying illegitimate drugs in supply chain

BY Antoinette Alexander

WASHINGTON — The Food and Drug Administration has published a draft guidance document for prescription drug supply chain stakeholders as part of the agency’s implementation of the Drug Supply Chain Security Act, the National Association of Boards of Pharmacy has reported.

The draft “Guidance for Industry: Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification” provides information about identifying and reporting suspect and illegitimate prescription drug products in the supply chain.

According to the NABP, the FDA is seeking public comment on the proposal by Aug. 11. Comments received by this deadline will be considered before the agency begins work on the final guidance, notes FDA. Signs of potentially illegitimate drug products discussed in the draft include:

  • Labels containing misspelled words or other deviations from standard labeling;
  • Products with unusual shapes, colors, or odors compared to standard products;
  • Packages missing identifying information such as the lot number or expiration date; and
  • Opened, damaged, repaired, or altered packaging seals.

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Merck begins tender offer to acquire Idenix

BY Antoinette Alexander

WHITEHOUSE STATION, N.J. — Merck announced on Friday that it is commencing, through a subsidiary, a cash tender offer to purchase all outstanding shares of common stock of Idenix Pharmaceuticals. On June 9, Merck announced its intent to acquire Idenix.

Upon the closing of the tender offer, stockholders of Idenix will receive $24.50 in cash for each share of Idenix common stock validly tendered and not validly withdrawn in the offer, without interest and less any required withholding taxes. Following the purchase of shares in the tender offer, Idenix will become a wholly owned subsidiary of Merck.

Merck will file Friday with the Securities and Exchange Commission a tender offer statement on Schedule TO, which provides the terms of the tender offer. In addition, Idenix will file with the SEC a solicitation/recommendation statement on Schedule 14D-9 that includes the recommendation of the Idenix board of directors that Idenix stockholders accept the tender offer and tender their shares.

The tender offer will expire at 5 pm EDT on Aug. 4, unless extended in accordance with the merger agreement and the applicable rules and regulations of the SEC. The closing of the tender offer is subject to customary terms and conditions, including the tender of a number of shares which, together with shares then owned by Merck (if any), represents a majority of the outstanding shares, and the expiration or the termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act.

 

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Teva reaches settlement in ProAir HFA patent case

BY Antoinette Alexander

JERUSALEM — Teva has reached a settlement with Perrigo Pharmaceutical and Catalent Pharma Solutions with respect to four patents for Teva’s ProAir HFA (albuterol sulfate) Inhalation aerosol product.

This settlement provides a license to Perrigo and Catalent to sell limited units of Perrigo’s generic version of the product for an initial period beginning Dec. 19, 2016 and lasting until June 2018, when the limits will no longer apply.

There are currently no additional challenges to the IP for ProAir HFA and no further litigation pending. Teva stated that it will continue to “vigorously” defend its intellectual property rights relating to its products.

 

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