On January 30, 2015, the U.S. Food and Drug Administration (FDA) approved a new formulation for all strengths of Zohydro ER, the single-agent, extended-release hydrocodone product, which is a schedule II controlled substance. Zohydro ER, manufactured by Zogenix, is indicated to treat severe chronic pain that needs continuous treatment and that has not been relieved by previous therapy options.
The new form is considered ‘abuse resistant’ and it is made with a proprietary technology called BeadTek. BeadTek creates thick, sticky goo if the capsules are opened or crushed and the specifies abuse resistance, however, Zogenix, is planning to provide the FDA with results of studies showing that the new formulation is difficult to abuse.
The first FDA approved version of Zohydro ER was approved in October 2013 without any abuse deterrents and will be phased out and replaced with the new form during the second quarter of 2015.
On February 17, 2015, Teva Pharmaceuticals announced the launch of its generic version of Nexium (esomeprazole magnesium delayed-release capsules) which received approval from the U.S. Food and Drug Administration (FDA) on January 23, 2015.
Nexium is a drug commonly used to treat gastroesophageal reflux (GERD), risk reduction of non-steroidal anti-inflammatory drug (NSAID)-associated gastric ulcers, Helicobacter pylori eradication to reduce the risk of duodenal ulcer recurrence and treatment of hypersecretory conditions (e.g. Zollinger-Ellison syndrome). The brand name Nexium is manufactured by AstraZeneca.
Teva will distribute its generic Nexium in 20 mg and 40 mg capsules.
Par Pharmaceutical Companies, Inc. announced that the US Food and Drug Administration (FDA) approved the AB-rated generic version of Exforge (amlodipine/valsartan). Brand Exforge is manufactured by Novartis. Exforge is used for the treatment of high blood pressure.
The generic of Exforge will be available in all current dosage strengths including 5mg/160mg, 10mg/160mg, 5mg/320mg and 10mg/320 mg tablets. Par Pharmaceutical Companies, Inc. was also granted 180 days exclusivity before any other new generics can be approved by the FDA. According to IMS health, Exforge saw annual sales of approximately $422 million.
On January 12, 2015, the generic equivalent to Clobex Spray, 0.05% was launched by Perrigo Company. The brand name Clobex Spray, 0.05% is manufactured by Galderma Laboratories.
Clobex Spray is indicated for the topical treatment of moderate to severe plaque psoriasis affecting up to 20% body surface area in adults.
Generics to Clobex Lotion and Shampoo are already available on the market.