FDA approves schizophrenia and anti-allergy drugs

Generics/News | Posted 18/02/2022 post-comment0 Post your comment

The US Food and Drug Administration (FDA) has granted tentative approvals to Zydus Cadila and Morepen Laboratories for treatments for schizophrenia and allergy symptoms, respectively.


In December 2021, Indian multinational Zydus Cadila received tentative approval from FDA to market its generic schizophrenia treatment, cariprazine.

Cariprazine is an atypical antipsychotic which targets dopamine receptors. It has been used in the treatment of schizophrenia and bipolar disorder and is sold under the brand name Vraylar by originator company AbbVie.

Zydus Cadila’s US subsidiary, Zydus Pharmaceuticals, received tentative approval for cariprazine capsules in 1.5 mg, 3 mg, 4.5 mg and 6 mg dosages for the treatment of schizophrenia and acute treatment of manic or mixed episodes associated with bipolar disorder. The drug will be produced at Zydus Cadila’s manufacturing facility in Ahmedabad, India.

FDA approved Zydus Cadila’s neuroleptic drug, fluphenazine hydrochloride, in May 2021, which can also be used to treat schizophrenia [1]. The company also received US approvals for its ibrutinib and macitentan generics earlier in 2021 [2], used for the treatment of certain cancers and hypertension, respectively.

In related news, India’s Morepen Laboratories (Morepen) has also received tentative approval for its generic anti-allergy drug, fexofenadine hydrochloride. Fexofenadine is an antihistamine sold under the brand name Allegra by originator firm Sanofi Aventis. It is the most widely used second-generation antihistamine for the treatment of allergy symptoms and hay fever. Morepen sells the product in India under the brand name Fexopen.

Morepen confirmed in a statement that it has already supplied validation quantities and that regular commercial supplies would begin after approval of these validation batches.

Morepen’s Chairman and Managing Director, Sushil Suri, commented: ‘Approval of anti-allergy drug Fexofinadine by US FDA is an important milestone in the company's therapeutic journey since it consolidates Morepen's position in the anti-allergy market with already having US FDA approval for three lead products Loratadine, Desloratadine and Montelukast’.

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1. GaBI Online - Generics and Biosimilars Initiative. FDA approval for schizophrenia and HIV generics from Zydus Cadila and Lupin [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Feb 18]. Available from: www.gabionline.net/generics/news/fda-approval-for-schizophrenia-and-hiv-generics-from-zydus-cadila-and-lupin
2. GaBI Online - Generics and Biosimilars Initiative. Zydus Cadila and Sandoz generics approvals in North America [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Feb 18]. Available from: www.gabionline.net/generics/news/Zydus-Cadila-and-Sandoz-generics-approvals-in-North-America

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Source: Zydus Cadila; Morepen Laboratories

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