Regulatory and Washington

ALLEGAN, Mich. The Food and Drug Administration has approved Perrigo's generic drug for treating skin diseases, the drug maker said Wednesday.

The FDA approved Perrigo’s imiquimod cream in the 5% strength. The drug is a generic version of Graceway Pharmaceuticals’ Aldara.

The drug is used to treat actinic keratoses on the face and scalp, superficial basal cell carcinoma and external genital and perianal warts in patients ages 12 years and older.

WHITEHOUSE STATION, N.J. Merck's supplemental drug applications for its atypical antipsychotic received approval from the Food and Drug Administration, the drug maker said.

Saphris now is indicated for the treatment of schizophrenia in adults, as monotherapy for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults, and as adjunctive therapy with either lithium or valproate for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults, Merck said.

MORRISTOWN, N.J. The Food and Drug Administration has approved a generic oral contraceptive made by Watson Pharmaceuticals, the drug maker said Tuesday.

Watson announced the FDA’s approval of Zarah (drospirenone and ethinyl estradiol tablets) in the 3 mg/0.03 mg strength. The drug is a generic version of Bayer’s Yasmin.

WASHINGTON The recently installed head of the federal Medicare program is pushing hard to promote new and more cost-effective ways to treat patients and improve the nation’s health scorecard.

ALEXANDRIA, Va. National Association of Chain Drug Stores president and CEO Steve Anderson and National Community Pharmacists Association acting EVP and CEO Douglas Hoey issued a statement praising the proposed rule by the Centers for Medicare and Medicaid Services that would withdraw existing provisions of the Medicaid pharmacy reimbursement formula under the average manufacturer price model.

MORRISTOWN, N.J. The Food and Drug Administration has approved a generic drug made by Actavis for treating attention deficit hyperactivity disorder, Actavis said Wednesday.

The FDA approved the drug maker’s atomoxetine hydrochloride capsules in the 10-mg, 18-mg, 25-mg, 40-mg, 60-mg, 80-mg and 100-mg strengths. The drug is a generic version of Eli Lilly’s Strattera, which had $532 million in sales during the 12-month period ended in June, according to IMS Health.

MUMBAI, India A generic drug maker has received regulatory approval for its version of an attention deficit hyperactivity disorder treatment.

Sun Pharmaceutical Industries' subsidiary has received approval to market its generic version of Strattera (atomoxetine hydrochloride capsules), an ADHD drug for children ages 6 years and older, as well as teens and adults. Strattera is made and marketed by Eli Lilly.

Annual sales of branded and generic atomoxetine hydrochloride capsules are estimated to be more than $530 million.

IRVINE, Calif. Allergan's optimized reformulation of Lumigan has received approval from the Food and Drug Administration, the drug maker said Wednesday.

Lumigan 0.01% (bimatoprost ophthalmic solution) is a first-line therapy indicated for the reduction of elevated intraocular pressure with open-angle glaucoma or ocular hypertension, Allergan said. Lumigan 0.01% will be available in fourth quarter 2010 as the newest addition to Allergan’s comprehensive glaucoma portfolio.