Lupin gets FDA nod for 2 generics
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.
Perrigo gets tentative FDA approval for generic Ultravate lotion
Perrigo has received tentative approval from the Food and Drug Administration for the first to file generic version of Ultravate lotion (halobetasol propionate) 0.05%.
Perrigo previously announced a patent litigation suit with Sun Pharmaceutical Industries and MiCal Pharmaceutical for this product.
Ultravate lotion 0.05% is indicated for the topical treatment of plaque psoriasis in patients age 18 years old and older.
The product had a market value of about $17 million for the 12 months ending September 2018, according to IQVIA.
“Our R&D team continues its efforts to secure regulatory approvals for important new products. This tentative approval reflects our continued dedication to developing extended topical products for patients and further illustrates our commitment to advancing our new product pipeline,” Perrigo executive vice president and president of Rx pharmaceuticals Sharon Kochan said.
Pfizer gets FDA green light for Daurismo
The Food and Drug Administration gave its blessing to Pfizer’s Daurismo (glasdegib) tablets to be used in combination with low-dose cytarabine, or LDAC, a type of chemotherapy, for the treatment of newly diagnosed acute myeloid leukemia, or AML in adults who are 75 years old or older or who have other chronic health conditions or diseases that may preclude the use of intensive chemotherapy.
“Intensive chemotherapy is usually used to control AML, but many adults with AML are unable to have intensive chemotherapy because of its toxicities. Today’s approval gives healthcare providers another tool to use in the treatment of AML patients with various, unique needs,” said Richard Pazdur, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Clinical trials showed that overall survival was improved using Daurismo in combination with LDAC compared to LDAC alone for patients who would not tolerate intensive chemotherapy.”
AML is a rapidly progressing cancer that forms in the bone marrow and results in an increased number of abnormal white blood cells in the bloodstream and bone marrow.
The National Cancer Institute at the National Institutes of Health estimates that in 2018, approximately 19,520 people will be diagnosed with AML, and approximately 10,670 patients with AML will die of the disease. Almost half of the adults diagnosed with AML are not treated with intensive chemotherapy because of comorbidities and chemotherapy-related toxicities.
The FDA granted this application Priority Review designation.
Daurismo also received Orphan Drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases.