Pliva will launch a generic oral suspension of Pfizer's antibiotic Zithromax (azithromycin) in the coming days following the lifting of an FDA hold on the company's ANDA submissions, Pliva announced July 7.

The hold was the result of a May FDA warning letter regarding manufacturing issues at the company's Zagreb, Croatia plant. The agency cited deficiencies in building maintenance, equipment cleaning and maintenance, lab and lab control calibration (¹ Also see "Pliva ANDA Approvals On Hold Following FDA Warning Letter" - Pink Sheet, 8 May, 2006.).

According to the agency's Center for Drug Evaluation & Research, Pliva is the only generic manufacturer to file an ANDA for the oral suspension formulation. The company already produces azithromycin tablets in several dosage strengths.

The release of the hold also resulted in approval for another ANDA, warfarin sodium tablets (Bristol-Myers Squibb's Coumadin ), as well as tentative approval for ondansetron (GlaxoSmithKline's Zofran ). Pliva said it would launch warfarin tablets "at a later date." Final approval for ondansetron is expected in June 2007, following expiration of 180-day exclusivity for another generic manufacturer.

Also on July 7, Barr, which is in a fierce bidding war with Actavis for takeover of Pliva, announced that it had submitted regulatory filings with the Federal Trade Commission and German regulators. Barr said discussions with FTC on July 5 over the potential acquisition did not raise any initial concerns.

Barr's bid is slightly higher than Actavis' bid per share, though both offers translate to about $2.3 bil. overall for Pliva (² Also see "Bidding War For Pliva Heats Up; Barr Edges Out $2.3 Bil. Offer From Actavis" - Pink Sheet, 30 June, 2006.).

-Jonathan Block

Two Pliva ANDAs Approved Following Lifting of FDA Hold

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