PHARMACY

Amneal launches felbamate oral suspension

BY Allison Cerra

BRIDGEWATER, N.J. — Amneal Pharmaceuticals has launched its generic version of a drug designed to treat seizures in adults and children with epilepsy.

The generic drug maker said it received approval from the Food and Drug Administration on Dec. 16 for felbamate oral suspension in the 600-mg/5-mL strength. The Amneal generic is available in two sizes, 8 fl. oz./240 mL and 16 fl. oz./473 mL. It is a generic version of Meda Pharmaceuticals’ antiepileptic Felbatol.

“This approval further expands our liquids portfolio and complements our tablet form of felbamate, which launched in September,” Amneal president Chirag Patel said. “Additionally, by bringing another first-to-market generic to the public, we are reinforcing our commitment to provide pharmacy customers and the consumer with high-quality, affordable pharmaceuticals.”


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PHARMACY

Bi-Lo, Winn-Dixie combo would create a $780 million-plus pharmacy operation

BY Michael Johnsen

GREENVILLE, S.C. — The proposed acquisition of Winn-Dixie by fellow Southeast grocer Bi-Lo would create a regional pharmacy operator with almost 500 pharmacy operations and pharmacy revenue of around $780 million, according to Drug Store News projections.

That would make the Bi-Lo/Winn-Dixie combination No. 24 on Drug Store News’ PoweRx50 — a list of the top 50 pharmacy retailers operating in the U.S. — falling in just behind Albertsons LLC (which posted $787 million in pharmacy revenue in 2010) and well ahead of Fred’s ($628 million).

And there will be no store closures associated with the mergers, according to both Bi-Lo and Winn-Dixie — the only potential for overlapping markets lay in Georgia, where Winn-Dixie operates 21 stores.

Both chains have come out of bankruptcy over the past decade — Winn-Dixie in 2006 and Bi-Lo more recently in 2010 — during which many of their underperforming operations already had been shuttered.

Today, both Bi-Lo and Winn-Dixie have put into play extensive remodel plans to help foster growth and interest in their respective banners. "We successfully grand-opened two more transformational remodeled stores that are generating promising financial results and building brand equity in their respective markets," Winn-Dixie chairman, president and CEO Peter Lynch told analysts in November, bringing the number of remodeled stores in operation to five.

Winn-Dixie’s transformational remodels generate between $400 and $500 in sales per sq. ft. vs. around $300 in sales per sq. ft. in a traditional Winn-Dixie. Already, Winn-Dixie had planned to roll out some of the learnings gleaned from the transformational remodels across its store base under the direction of Larry Appel, SVP retail operations. Appel could play a key role in applying any Winn-Dixie learnings to Bi-Lo’s remodel program.

Before the proposed merger, Winn-Dixie had planned to institute its transformational format across 60% of its store base, or 290 stores.

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Independents providing LTC could face challenges under newly proposed CMS regulations

BY Michael Johnsen

ALEXANDRIA, Va. — According to the National Community Pharmacists Association, changes governing long-term care facilities that recently were proposed by the Centers for Medicare and Medicaid Services could create turmoil for independent community pharmacies providing LTC services, the association stated in a release Wednesday.

"In response to inadequate data and the alleged wrongdoing by one national, LTC pharmacy corporation, CMS has suggested requiring all LTC facilities to contract solely with consultant pharmacists who have no affiliations to any in-facility LTC pharmacy, pharmaceutical manufacturer or drug wholesaler," the association stated.

A November 2011 survey of NCPA members supported the concerns expressed in NCPA’s comments. Namely, respondents indicated that 80% of the LTC facilities that they serve are in rural areas. Further, most pharmacists surveyed said that, in the communities that their LTC pharmacies serve, there already is a shortage of consultant pharmacists, which NCPA argued would become worse under CMS’ proposal.

In addition, the overwhelming majority of respondents asserted that CMS’ proposed requirement would be detrimental to LTC facilities’ efficiencies, continuity of care, timeliness of care and services, as well as communication between healthcare providers.

If CMS ultimately decides to implement such changes, the agency should delay the effective date past the proposed Jan. 1, 2013, date, NCPA added. That’s because another significant regulatory requirement — that LTC pharmacies dispense certain high-cost drugs in shorter, 14-day (or less) cycles — also is set to take effect on that date.

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