Content about Food and Drug Administration

PITTSBURGH The Food and Drug Administration has approved a generic chemotherapy drug made by Mylan.

The Pittsburgh-based drug maker said Monday that it had received approval for the injected drug fludarabine phosphate in the 25-mg-per-mL strength. The FDA determined the drug to be therapeutically equivalent to Teva Parenteral’s fludarabine phosphate.

FLORHAM PARK, N.J. The Food and Drug Administration has approved a nonstimulant drug for treating attention deficit hyperactivity disorder.

Shionogi announced Monday the approval of Kapvay (clonidine hydrochloride), an extended-release drug for treating ADHD in children and adolescents ages 6 to 17 years. The company said Kapvay was the only formulation of clonidine hydrochloride approved for treating ADHD and the first ADHD treatment approved for use as an add-on therapy to stimulant drugs.

WASHINGTON McNeil products soon will repopulate shelves, Johnson & Johnson chairman and CEO Bill Weldon shared on Thursday during his testimony before the House of Representatives Committee on Oversight and Government Reform.

MUMBAI, India The Food and Drug Administration has given tentative approval to a generic cholesterol drug made by Sun Pharmaceutical Industries.

Sun announced Wednesday the tentative approval of rosuvastatin calcium tablets in the 5-mg, 10-mg, 20-mg and 40-mg strengths.

ABBOTT PARK, Ill. Abbott has received market clearance from the Food and Drug Administration for RevitaLens Ocutec, a multipurpose disinfecting solution for silicone hydrogel and conventional soft contact lenses.

SILVER SPRING, Md. The Food and Drug Administration on Tuesday issued warning letters to three companies that manufacture and market mouth rinse products with claims that they remove plaque above the gum line or promote healthy gums. According to the FDA, these claims suggested the products are effective in preventing gum disease when no such benefit has been demonstrated.

Warning letters were sent to: Johnson & Johnson (Listerine total care anti-cavity mouthwash), CVS (CVS complete care anti-cavity mouthwash), and Walgreens (Walgreen mouth rinse full action).

MUMBAI, India The Food and Drug Administration has approved a generic version of a drug for a devastating muscular disorder.

Sun Pharmaceutical Industries announced Tuesday the approval of riluzole hydrochloride in the 50-mg strength. The tablets are used to treat amyotrophic lateral sclerosis or ALS, also known as Lou Gehrig’s disease.

The drug is a generic version of Sanofi-Aventis’ Rilutek, which has sales of around $50 million, according to Sun.

SILVER SPRING, Md. The Food and Drug Administration has approved a new oral contraceptive from Bayer HealthCare Pharmaceuticals.

The FDA announced Friday the approval of Beyaz (estrogen and progestin) tablets. The pills also contain a folate known as levomefolate calcium. Low folate levels in the body are associated with such conditions as spina bifida, and physicians recommend that women of childbearing age supplement their diets with folate.

PEAPACK, N.J. —The generics subsidiary of Pfizer is launching a new business focused on authorized generics. Greenstone announced the launch of the Authorized Generics Alliance, which it said would combine its business model and 17 years of experience in the generics market with the expertise of other drug makers to market authorized generics in the United States under the Greenstone label.

STOCKHOLM An investigational diabetes drug works as well as a generic already on the market, according to results of a late-stage clinical trial announced Friday by AstraZeneca and Bristol-Myers Squibb.

LONDON The Food and Drug Administration has accepted AstraZeneca’s regulatory application for an investigational cancer drug, the Anglo-Swedish drug maker said Thursday.

AstraZeneca announced the FDA’s acceptance of its application for vandetanib, a drug for treating patients with advanced medullary thyroid cancer. The agency gave the drug priority review status and expected to take action on it in January.