Diplomat announces availability of Lilly’s Taltz
BY DSN STAFF
FLINT, Mich. — Diplomat Pharmacy announced Tuesday that it had been selected as part of Eli Lilly and Co.’s limited-distribution network for its recently approved plaque psoriasis treatment Taltz (ixekizumab).
"Psoriasis is a serious chronic disease that can have debilitating symptoms," Diplomat president Gary Kadlec said. “Taltz enables patients an important treatment option.”
Information about Diplomat’s psoriasis program can be found here.
ANI gets FDA approval for oxycodone, launches hydrocortisone rectal cream
SILVER SPRING, Md. and BAUDETTE, Minn. — ANI Pharmaceuticals on Tuesday announced the Food and Drug Administration approval for one new generic and the launch of another.
The company received FDA approval for its generic of oxycodone HCl capsules. The drug will be available in 5-mg dosage strength, and it saw annual sales of $7.5 million for the 12 months ended February 2016, according to IMS Health. The drug is indicated to manage moderate to severe acute and chronic pain when opioid use is appropriate.
“When launched, this will be our third commercial Schedule II narcotic product,” ANI president and CEO Arthur Przybyl said. “In addition, we have received a target action date of January 2, 2017 from the FDA for another Schedule II narcotic product. We remain hopeful that we will obtain three additional Schedule II narcotic product approvals within the next 12 months.”
The company also announced the launch of its hydrocortisone retal cream 1% and 2.5%. The cream is indicated for relief of corticosteroid dermatoses. The two products saw annual sales of about $84 million for the 12 months ended February 2016, according to IMS Health.
“We are excited to add these niche topical products to our growing generic portfolio,” Przybyl said.
Gilead’s new HIV drug Descovy gets FDA approval
SILVER SPRING, Md. — The Food and Drug Administration has approved a new treatment for HIV from Gilead Sciences. The company announced Monday that it had received the agency’s approval for Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg, F/TAF).
The drug is indicated to treat HIV in combination with other antiretroviral agents in patients 12 years of age and older. It is not indicated as pre-exposure prophylaxis to reduce the risk of contracting sexually acquired HIV-1. Descovy has a similar antiviral efficacy to Gilead’s Viread (tenofovir disoproxil fumarate), but contains one-tenth the dose of tenofovir as Viread, the company said.
“As the first new HIV treatment backbone approved by the FDA in more than a decade, Descovy represents an important evolution in HIV care,” Gilead chief scientific officer and EVP research and development Norbert Bischofberger said. “As part of a single tablet regimen or partnered with a third agent, the components of Descovy offer patients a simple and effective combination with a safety profile that has the potential to improve health.”
Descovy comes with a boxed warning about the risk of lactic acidosis/severe hepatomegaly with steatosis, as well as post-treatment acute exacerbation of hepatitis B.
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