Generics

BD (Becton, Dickinson and Company), a leading global medical technology company, today announced that the U.S. Food and Drug Administration (FDA) has approved the first drug to be offered in the just-launched BD Simplist™ ready-to-administer, line of prefilled generic injectables. BD Simplist prefilled injectables will be commercialized and manufactured by BD Rx Inc., a wholly-owned subsidiary of BD.  The first BD Simplist product BD Rx will launch is Diphenhydramine Hydrochloride Injection, USP, an injectable antihistamine. 

Generic drugs have dramatically changed the pharmaceutical and health-care landscape in the last 25 years and now account for about 80 percent of prescriptions in the United States, with lower prices for consumers and insurers.

But a U.S. Supreme Court case scheduled for argument March 25 pits drug companies, generic and branded, against government officials who argue that prices for consumers would be even lower if those companies did not strike deals to restrain trade. Drugstore chains and health insurers back the government's side.

Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Applications (ANDA) for Rizatriptan Benzoate Orally Disintegrating Tablets, 5 mg (base) and 10 mg (base), and Rizatriptan Benzoate Tablets, 5 mg (base) and 10 mg (base). These products are the generic versions of Merck's Maxalt MLT® Tablets and Maxalt® Tablets, respectively, and are indicated for the acute treatment of migraine with or without aura in adults.

Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Candesartan Cilexetil and Hydrochlorothiazide Tablets, 16/12.5 mg, 32/12.5 mg and 32/25 mg. This product is the generic version of AstraZeneca's Atacand HCT, and is indicated for the treatment of hypertension. This fixed dose combination is not indicated for initial therapy.

Teva Pharmaceutical Industries announced the launch of an authorized generic of Actos (pioglitazone-hydrochloride tablets) 15, 30 and 45mg. Actos is marketed by Takeda Pharmaceuticals U.S.A., Inc., and used with diet and exercise for blood sugar control in adults with type 2 diabetes.

The brand product had annual sales of approximately $2.7 billion in the United States, based on IMS sales data as of June 30.

Pharmaceutical and biotechnology major Wockhardt has received final approval from the United States Food & Drug Administration (US FDA) for marketing 10mg extended release tablets of Alfuzosin hydrochloride, which is used in treatment of Benign Prostatic Hyperplasia or enlarged prostate. Alfuzosin is the generic name for the brand Uroxatral marketed in the United States by Sanofi-Aventis. Wockhardt is launching the product immediately.

Watson Pharmaceuticals, Inc. today announced that its subsidiary Watson Laboratories, Inc., has received approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Budesonide Inhalation Suspension 0.25mg/2mL and 0.5mg/2mL Unit-dose ampules, the generic equivalent to AstraZeneca's Pulmicort RESPULES. Watson is currently involved in patent litigation with AstraZeneca concerning this product.

Watson Pharmaceuticals, Inc. (NYSE: WPI) today announced that its subsidiary Watson Laboratories, Inc., has received approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Next Choice™ ONE DOSE (Levonorgestrel Tablet, 1.5 mg), the generic equivalent to Teva Women's Health's Plan B One-Step. Watson plans to launch the product immediately.

Bayshore Pharmaceuticals announces that it has acquired a pending Abbreviated New Drug Application (“ANDA”) via an Asset Purchase Agreement with a large US-based generic pharmaceutical company. Based on industry sales data, the product, which is expected to gain full FDA approval within the next quarter, has reported U.S. sales of approximately $12 million over the previous 12 month period.