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FDA approvals for generic AIDs and testosterone drugs Posted 19/09/2014

The US Food and Drug Administration (FDA) has approved generic versions of drugs to treat appetite loss in AIDs patients and a testosterone gel treatment for men.

TWi Pharmaceuticals (TWi) announced on 28 August 2014 that it had received final approval from FDA for its abbreviated new drug application (ANDA) for megestrol acetate 125 mg/mL oral suspension. The drug is a generic equivalent to Par Pharmaceutical’s (Par) Megace ES (megestrol), which is used to treat appetite loss, severe malnutrition, or unexplained, significant weight loss in AIDS patients. TWi is currently prevented from launching the product due to an injunction from Par.

Total annual sales of megestrol products in the US were approximately US$57 million for the 12 months ending 30 June 2014, according to IMS Health.

Endo International (Endo) announced on 8 September 2014 that it had introduced the first and only generic 2% topical testosterone gel, an authorized generic of Fortesta Gel (testosterone gel) CIII. Fortesta Gel and its authorized generic version are the first and only 2% testosterone gels approved by FDA to treat adult males diagnosed with hypogonadism – a condition in which the body does not produce enough testosterone.

Endo’s generics subsidiary Qualitest will be responsible for the distribution of the authorized generic drug, while Endo will be responsible for its promotion. Endo will also continue to be responsible for the distribution and promotion of 2% Fortesta Gel.

Opinion on authorized generics is divided. Some believe that they are pro-competitive – offering drugs to consumers at lower prices than the brand-name product. Others, however, believe that authorized generics harm competition by drawing revenues away from generics firms during the 180-day exclusivity period provided for the first-to-file. Nevertheless, a report from the US Federal Trade Commission found that authorized generics modestly reduce drug prices during the first 180 days of generics competition [1].

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Reference
1.   GaBI Online - Generics and Biosimilars Initiative. Authorized generics reduce drug prices [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Sep 19]. Available from: www.gabionline.net/Reports/Authorized-generics-reduce-drug-prices

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Source: Endo, TWi

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