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PHARMACY

AbbVie gets FDA clearance for new Venclexta indication

BY Sandra Levy

AbbVie has received the Food and Drug Administration’s nod for Venclexta (venetoclax tablets) in combination with azacitidine, or decitabine, or low-dose cytarabine for the treatment of newly diagnosed acute myeloid leukemia, or AML, in adults age 75 years old or older, or who have comorbidities that preclude use of intensive induction chemotherapy.

“AML is an extremely aggressive and debilitating blood cancer, and outcomes for patients ineligible for intensive chemotherapy are very poor,” AbbVie executive vice president of research and development and chief scientific officer Michael Severino said.”This new approval for Venclexta marks a significant milestone for AbbVie and, more importantly, for patients diagnosed with this deadly disease. We look forward to continuing our work developing Venclexta and advancing treatment options in other aggressive cancers.”

Venclexta is an oral B-cell lymphoma-2 inhibitor. It is now approved for use in two different blood cancers: newly-diagnosed AML and relapsed/refractory chronic lymphocytic leukemia.

The approval in AML is the third provided under priority review by the FDA for Venclexta, which has been granted four Breakthrough Therapy Designations by the FDA.

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Ruling revives launch of Dr. Reddy’s generic Suboxone sublingual film

BY Sandra Levy

Dr. Reddy’s will resume its launch of generic Suboxone sublingual film, an opioid treatment drug, following a ruling by the United States Court of Appeals for the Federal Circuit in favor of the company.

The ruling concluded that Indivior had not shown that it is likely to succeed on the merits of its infringement case on U.S. Patent No. 9,931,305.

This decision vacates the District Court’s preliminary injunction that had prohibited Dr. Reddy’s from selling its generic version of Suboxone (buprenorphine and naloxone) sublingual film.

“We are pleased with the decision of the appellate court in Dr. Reddy’s favor, vacating the preliminary injunction that had prevented Dr. Reddy’s from bringing this important drug to the public. We are committed to providing affordable and innovative medicines that address the unmet and under-met needs of patients around the world and, in particular, look forward to taking the lead in helping to fight opioid use disorder,” a company spokesperson said.

In June, the FDA approved Dr. Reddy’s buprenorphine and naloxone sublingual film in four strengths, including 2 mg/0.5 mg, 4 mg/1 mg, 8 mg/2 mg, and 12 mg/3 mg. The product was launched immediately after approval, with sales and commercialization activities halted as a result of a court imposed temporary restraining order, or TRO, against Dr. Reddy’s.

The TRO did not include a prohibition on commercial manufacturing of the product.

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Lupin gets FDA nod for 2 generics

BY Sandra Levy

Lupin has received the Food and Drug Administration’s blessing for clomipramine hydrochloride capsules in 25-, 50- and 75-mg dosage strengths. The product is a generic version of SpecGx’ s Anafranil capsules.

It is indicated for the treatment of obsessions and compulsions in patients with obsessive-compulsive disorder

Anafranil capsules, 25 mg, 50 mg, and 75 mg had a market value of approximately $109.6 million, according to IQVIA September 2018 data.

The FDA also approved Lupin’s potassium chloride for oral solution, 20 mEq.

The product, which is a generic version of Pharma Research Software Solution’s potassium chloride for oral solution, 20 mEq, is indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient.

The product had a market value of approximately $105 million, according to September 2018 IQVIA data.

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