Industry Briefs

FDA Approves Pfizer’s Methylphenidate Extended-Release Chewable Tablets

Earlier this month, Pfizer announced that the Food and Drug Administration (FDA) has approved QuilliChew ER (methylphenidate HCl) chewable tablets intended to treat patients 6 and older for attention-deficit/hyperactivity disorder (ADHD).

QuilliChew ER will be available in 20 mg scored, 30 mg scored, and 40 mg unscored tablets and can be taken with or without food.

Pfizer warns that because CNS stimulants have a high potential for abuse and dependence, physicians should assess their patients’ risks for abuse prior to prescribing and monitor patients for signs of abuse and dependence while taking the medication.

The medication is not recommended for patients known to be hypersensitive to methylphenidate or other components of QuilliChew ER; it is also contraindicated for patients during treatment with monoamine oxidase inhibitors (MAOIs) or within 14 days following discontinuation of treatment with an MAOI.

QuilliChew ER is expected to be available in pharmacies in the first quarter of 2016.

Generic Version of Paxil Gets FDA Nod

Jubilant Life Sciences Ltd has received FDA approval for its generic version of the Paxil (paroxetine) tablets. The generic, marketed as Apotex, was approved under the Abbreviated New Drug Application, which maintains the product is bioequivalent to Paxil. Apotex will be available in strengths of 10 mg, 20 mg, 30 mg, and 40 mg tablets. ■