HAYWARD, Calif., Jan. 15, 2016 /PRNewswire/ — Impax Laboratories, Inc. (NASDAQ: IPXL) today appear that the United States Food and Biologic Administration (FDA) has accustomed the Company’s added new biologic appliance (sNDA) for EMVERM (mebendazole) 100 mg chewable tablets.
EMVERM is adumbrated for the analysis of Enterobius vermicularis (pinworm), Trichuris trichiura (whipworm), Ascaris lumbricoides (common roundworm), Ancylostoma duodenale (common hookworm), Necator americanus (American hookworm) in distinct or alloyed infections. Pinworm is a awful catching bacteria that infects about 40 actor bodies in the United States anniversary year.1 Pinworm infection is three times added accepted than arch lice.2 EMVERM is not for bodies who accept apparent hypersensitivity to the drug.
“We are admiring to advertise the approval of EMVERM, a new decree artefact for the analysis of pinworm and assertive bastard infections,” said Fred Wilkinson, President and Chief Executive Officer of Impax. “EMVERM is an important analysis advantage for pinworm as it offers a 95% analytic cure amount in a distinct 100 mg dose.3 We currently apprehend to admit bartering administration of EMVERM aboriginal in the additional analysis of 2016.”
“As allotment of our action aeon plan to enhance our anthelmintic authorization in accession to ALBENZA® (albendazole), with this approval, we can now action an anthelmintic to amusement the best accepted bastard infections in the United States. Additionally, the approval of ENVERM added leverages the cardinal allowances of the Tower Holdings acquisition4,” Mr. Wilkinson concluded.
ALBENZA is adumbrated for the analysis of parenchymal neurocysticercosis due to alive lesions acquired by abecedarian forms of the pork tapeworm, Taenia solium. ALBENZA is additionally adumbrated for the analysis of cystic hydatid ache of the liver, lung, and peritoneum, acquired by the abecedarian anatomy of the dog tapeworm, Echinococcus granulosus. ALBENZA is contraindicated in patients with accepted hypersensitivity to the benzimidazole chic of compounds or any apparatus of ALBENZA.
EMVERM (mebendazole) Important Assurance Information
Mebendazole is contraindicated in bodies who accept apparent hypersensitivity to the drug
Warnings: There is no affirmation that mebendazole, alike at aerial doses, is able for hydatid disease. There accept been attenuate letters of neutropenia and agranulocytosis back mebendazole was taken for abiding periods and at dosages essentially aloft those recommended.
Precautions: Alternate appraisal of agency arrangement functions, including hematopoietic and hepatic, is adapted during abiding therapy.
Information for Patients:
Drug Interactions: Preliminary affirmation suggests that cimetidine inhibits mebendazole metabolism and may aftereffect in an access in claret concentrations of mebendazole.
Pregnancy Category C: Mebendazole has apparent embryotoxic and teratogenic action in abundant rats at distinct articulate doses as low as 10 mg/kg (approximately according to the animal dose, based on mg/m2). In appearance of these allegation the use of mebendazole is not recommended in abundant women.
Nursing Mothers: It is not accepted whether mebendazole is excreted in animal milk. Because abounding drugs are excreted in animal milk, attention should be acclimatized back mebendazole is administered to a nursing woman.
Pediatric Use: The biologic has not been abundantly advised in accouchement beneath two years; therefore, in the analysis of accouchement beneath two years the about benefit/risk should be considered.
Gastrointestinal: Transient affection of belly affliction and diarrhea with banishment of worms in cases of massive infection.
Hypersensitivity: Rash, urticaria and angioedema accept been empiric on attenuate occasions.
Central Afraid System: Very attenuate cases of amusement accept been reported.
Liver: There accept been alarmist action analysis elevations [AST (SGOT), ALT (SGPT), and GGT] and attenuate letters of hepatitis back mebendazole was taken for abiding periods and at dosages essentially aloft those recommended.
Hematologic: Neutropenia and agranulocytosis. (See WARNINGS above).
Overdosage: In the accident of adventitious overdosage, gastrointestinal complaints abiding up to a few hours may occur. Vomiting and ablution should be induced. Activated charcoal may be given.
You are encouraged to address abrogating ancillary furnishings of decree drugs to the FDA. Appointment www.fda.gov/medwatch or alarm 1-800-FDA-1088. To address SUSPECTED ADVERSE REACTIONS acquaintance Impax Laboratories, Inc. at 1-877-994-6729.
For abounding Prescribing Advice see http://documents.impaxlabs.com/emverm/pi.pdf.
ALBENZA (albendazole) Important Assurance InformationContraindicationsALBENZA is contraindicated in patients with accepted hypersensitivity to the benzimidazole chic of compounds or any apparatus of ALBENZA.
Warnings and PrecautionsFatalities accept been appear due to cartilage bottom suppression; adviser claret counts in all patients at the alpha of anniversary 28-day aeon of therapy, and every 2 weeks while on analysis Abandon ALBENZA in all patients if clinically cogent changes in claret counts occur.
Obtain abundance analysis in women of changeable abeyant above-mentioned to analysis and abstain accepting in abundant women except in analytic affairs were no another administration is appropriate. Abandon analysis if abundance occurs and accustom accommodating of abeyant hazard to the fetus.
Neurocysticercosis patients may acquaintance bookish hypertensive episodes, seizures or focal neurologic deficits afterwards admission of therapy; activate adapted steroid and anticonvulsant therapy.
Cases of retinal captivation accept been reported; appraise the accommodating for the attendance of retinal lesions afore initiating analysis for neurocysticercosis.
Elevations of alarmist enzymes may occur. Adviser alarmist enzymes afore the alpha of anniversary analysis aeon and at atomic every 2 weeks while on ALBENZA analysis and abandon if clinically cogent elevations occur.
Undiagnosed neurocysticercosis may be baldheaded in patients
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