PHARMACY

Perrigo gets FDA OK for generic Androgel packets

BY David Salazar

SILVER SPRING, Md. — The Food and Drug Administration has approved Perrigo’s generic of AbbVie’s Androgel Topical Gel 1.62% packets (testosterone 20.25 mg/1.25 g packet and 40.5 mg/2.5 g packet).

The drug is an androgen indicated for replacement therapy in makes for conditions associated with an absence or deficiency of endogenous testosterone. The drug had annual U.S. sales of $88 million for the 12 months ended May 2017, according to QuintilesIMS data. Perrigo said the approval was for its first-to-file application. 

"This final approval is another example of our long-term investment in new products,” Perrigo EVP and president Rx harmaceuticals John Wesolowski said. “The Rx team remains committed to providing affordable treatments options for patients in important extended topical categories."

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FDA approves Impax’s generic extended-release Concerta

BY David Salazar
SILVER SPRING, Md. — The Food and Drug Administration has approved Impax Laboratories’ generic of Concerta (methylphenidate hydrochloride) extended-release tablets. The drug is indicated too treat attention deficit hyperactivity disorder in patients older than 6 years of age.
 
“Approval of our AB-rated generic version of Concerta further demonstrates the capabilities of Impax's R&D organization,” Impax president and CEO Paul Bisaro said. “We are preparing for launch including working to secure API quota and currently expect to launch by the end of this year. As a result, we don't anticipate sales of generic Concerta to meaningfully impact our earnings in 2017.”
 
Impax’s generic will be available in 18-, 27-, 36- and 54-mg dosage strengths. The drug had U.S. sales of approximately $1.8 billion for the 12 months ended May 2017, according to QuintilesIMS data. 
 

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Report: Jean Coutu criticizes government negotiations regarding dispensing fees

BY DSN STAFF

Jean Coutu founder Jean Coutu spoke out regarding negotiations with Quebec around dispensing fees, according to a report published last week by Canada's Bell Media. Jean Coutu earlier this year agreed to surrender $300 million in collected dispensing fees in return for smaller manufacturer rebates that cut into pharmacy operating margins. "It is an average of $100,000 for each of our locations," Coutu told shareholders BellMedia reported. "It was extremely difficult to digest." (Bell Media)

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