A.forall Announces the Launch of Their Fifth Abbreviated New Drug Application (ANDA) and Second “First Cycle” FDA Approval
25 Julio 2024 - 3:00AM
Business Wire
A.forall’s U.S. subsidiary Milla Pharmaceuticals Inc. announced
the launch of the group’s generic version of Precedex®,
Dexmedetomidine Hydrochloride Injection 200 mcg per 50 mL and 400
mcg per 100 mL in 0.9% sodium chloride in glass bottles by its
partner Sagent Pharmaceuticals.
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the full release here:
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Dexmedetomidine Hydrochloride Injection is indicated for
sedation of initially intubated and mechanically ventilated
patients during treatment in an intensive care setting.
Dexmedetomidine Hydrochloride Injection 200 mcg per 50 mL and
400 mcg per 100 mL is currently on FDA’s Drug Shortages list. This
latest launch of Dexmedetomidine Hydrochloride Injection will help
reduce the recent supply issues for the product experienced in the
U.S.
The product is now launched after having obtained a so-called
“First Cycle” Approval ANDA (abbreviated new drug application),
meaning it was approved on the first cycle of an FDA review, which
was also the case for A.forall’s Sodium Acetate Injection
2mEq/mL.
Dexmedetomidine Hydrochloride Injection is the fifth A.forall
Abbreviated Drug Application that Milla Pharmaceuticals introduces
into the U.S. market and also marks the second successful Paragraph
IV Filing.
“While many others struggle to crack the scientific and
regulatory complexity of launching a product on the U.S. market,
with Dexmedetomidine Hydrochloride Injection, our team managed to
bring yet another product to U.S. patients of which there is a
critical shortage. And that’s exactly what at A.forall we get out
of bed for every morning: offer high-quality, affordable medicines
to patients in need, whether in the U.S., the EU or the rest of the
world. We are only at the beginning of our journey of making
affordable medicines available to all”, commented A.forall CEO
Filip Van de Vliet.
According to IQVIA®, U.S. annual sales for Dexmedetomidine
Hydrochloride for the 12 months ended May 2024 were approximately
$117 million.
Please see link for Full Prescribing Information.
About A.forall & Milla Pharmaceuticals
At A.forall, we Make Affordable Medicines Available To All: we
develop value-added generic pharmaceuticals, solve product
shortages and fill unmet medical needs so that patients can
continue their treatment.
At the same time, we are reducing costs to the healthcare system
and increasing customer convenience for a more sustainable
world.
Milla Pharmaceuticals Inc., the U.S. subsidiary of A.forall, is
engaged in the development, licensing, acquisition, and
commercialization of generic prescription drugs for the U.S.
market, focusing on niche injectable and solution products for
hospitals and clinics.
More info: About – A.forall & About - Milla Pharmaceuticals
Inc.
About SAGENT Pharmaceuticals
SAGENT Pharmaceuticals® is a leading provider of injectable
pharmaceuticals. Sagent’s extensive product portfolio offers
flexibility across diverse therapeutic categories and packaging
configurations including vials, syringes, and premix bags,
fulfilling the evolving needs of patients. Discover Injectables
Excellence®: Visit www.sagentpharma.com and follow us on
LinkedIn.
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version on businesswire.com: https://www.businesswire.com/news/home/20240725206233/en/
Erik Lazarich 1 (651) 231-1042
erik.lazarich@aforallpharma.com